(26 days)
GORE-TEX® Periodontal Material
Not Found
No
The device description and performance studies focus on the material properties and clinical outcomes of a bioabsorbable polymer barrier for guided tissue regeneration. There is no mention of AI or ML in the text.
Yes
The device is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components, which is a therapeutic purpose.
No
This device, ATRISORB® GTR Barrier, is indicated for the surgical treatment of periodontal defects to aid in regeneration and integration of tissue components. It is a therapeutic device that facilitates healing, not a device used to diagnose a medical condition.
No
The device description clearly outlines a physical, bioabsorbable polymer formulation provided in kits with hardware components like a barrier forming case, porous pads, spacers, and cannulae. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the surgical treatment of periodontal defects to aid in tissue regeneration in vivo (within the body).
- Device Description: The device is a bioabsorbable polymeric formulation applied directly to the surgical site.
- Mechanism of Action: It functions by isolating the surgical site to facilitate regeneration in vivo.
- Performance Studies: The performance studies involve clinical trials and animal studies evaluating the device's effect on tissue regeneration in vivo.
- No mention of testing samples from the human body: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted into the body.
Therefore, ATRISORB® GTR Barrier is a medical device used for surgical treatment and tissue regeneration in vivo, not an IVD.
N/A
Intended Use / Indications for Use
ATRISORB® GTR Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB® GTR Barrier is not intended for use in defects outside the indications statement.
Product codes (comma separated list FDA assigned to the subject device)
NPK
Device Description
The ATRISORB® polymer formulation is a sterile, synthetic flowable polymeric formulation which is bioabsorbable and has been developed for GTR procedures by Atrix Laboratories, Inc. It consists of a polymer of lactic acid, poly(DL-lactide) (PLA), dissolved in N-methyl-2-pyrrolidone (NMP).
The finished device is provided in two different packaging configurations. The first configuration is the ATRISORB® GTR Barner Kit (case kit) used to form either with the barrier-forming case (extraoral) or by direct application over bone grafting material. The second configuration is the ATRISORB® GTR Barrier multipack (multipack) used only for the direct application technique.
The ATRISORB® GTR Barrier Kit configuration contains a foil-pouched, single-patient use dose pack containing 0.5 g of ATRISORB® polymer formulation, a pouched tray that contains a barrier forming case and three units of 0.9% sodium chloride solution (pH range 3.5 - 6.0), and an instructions for use booklet.
The barrier forming case has two sections of porous pads held in the cavities of the case and two spacers that are loose in the case. A label with a 1 mm grid pattern is affixed to the underside of the case. This grid is visible through the case and allows an area on the inside of the case to be used for trimming the formed barrier
The ATRISORB® GTR Barrier multipack configuration consists of three foilpouched, single patient use dose packs containing 0.5 g of the ATRISORB® polymer formulation, three 18 gauge cannulae, and an instructions for use booklet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal defects
Indicated Patient Age Range
Between the ages of 25 and 75.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of In Vitro Studies:
- Cytotoxicity: Evaluated toxic effects on L929 cells, found mildly cytotoxic, but in vivo and clinical studies show different results.
- Sensitization: Guinea pig maximization test, ATRISORB® polymer formulation is not a skin sensitizer.
- Genotoxicity: Evaluated mutagenicity of an extract, ATRISORB® polymer formulation is not mutagenic.
- Pyrogenicity: LAL test, ATRISORB® polymer is non-pyrogenic.
- Hemolysis: ATRISORB® GTR barrier causes hemolysis in in vitro test, but unlikely in patients due to high concentrations in assay not reflective of human body.
- Sterilization: Terminally sterilized by Cobalt 60 irradiation.
- Bioburden: Determined prior to sterilization using USP procedures.
Summary of In Vivo Implantation Studies:
- Subchronic Implantation: Evaluated biocompatibility in rats. No toxicity observed around implantation sites.
- Chronic Implantation and Biodegradation: Evaluated degradation kinetics and tissue response in rabbits for up to twelve months. No biologically significant changes or abnormal tissue observed. Biodegradation expected by 13-14 months.
Summary of Animal Efficacy Studies:
- Histology Study: Compared ATRISORB® GTR barriers to sham operated controls in six adult beagle dogs for a six-month observation period to treat furcation defects. Demonstrated clinically and statistically superior results in position, significantly increased vertical and horizontal furcation depth, and improved periodontal regeneration (new bone, cementum, periodontal ligament formation). No signs of toxicity.
- Biodegradation and Safety Study: Evaluated clinical application, management, safety, and biocompatibility in seven beagle dogs with 17 naturally occurring defects. Twelve furcation defects treated with ATRISORB® GTR barriers. Well tolerated and produced no increases in localized inflammation. No clinical or histological evidence of adverse healing or toxicity after one year. Complete absorption at 12 months with one exception.
- Pilot Study: Examined four compositions of ATRISORB® polymer formulation in six beagle dogs with 39 defects. New periodontal supporting tissues reconstituted on root surfaces.
- Feasibility Study: Evaluated safety and potential of flowable polymer in two dogs with 10 test sites and 8 control sites over 3 months. Demonstrated potential safety and ability to facilitate tissue regeneration.
Summary of Pivotal Trial:
- Study Type: Multicenter clinical trial under an FDA Investigational Device Exemption.
- Primary Objective: Demonstrate substantial equivalence of ATRISORB® GTR Barrier Kit to GORE-TEX® periodontal material for guided tissue regeneration of Class II furcation defects in humans.
- Clinical End Points: Vertical and horizontal attachment level, probing pocket depth, bleeding on probing, gingival margin location, and gingival index.
- Study Design: Multicenter study with a parallel design.
- Sample Size: 162 subjects randomized and entered into the 52-week study. 82 subjects received ATRISORB® GTR barrier, 80 subjects received GORE-TEX® periodontal material.
- Inclusion Criteria: Class II furcation with vertical pocket depth >=5 mm and attachment loss at the site, horizontal depth of furcation >=3 mm, ages 25-75, in good general health, evidence of crestal alveolar bone loss from periodontitis.
- Key Results: Substantially equivalent to the predicate device.
- Vertical Attachment Level: Mean gain for ATRISORB® was 0.38 mm greater than GORE-TEX® at Week 52. Null hypothesis (GORE-TEX® superior by at least 0.5 mm) rejected (p
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the date "SEP 8 1998". The month is abbreviated to three letters. The day is a single digit, and the year is four digits.
2579 MIDPOINT DRIVE FORT COLLINS, CO 80525-4417 U.S.A.
Image /page/0/Picture/2 description: The image shows the logo for Atrix Laboratories, Inc. The logo features a stylized sunburst design above the company name. The sunburst is composed of several thick, black lines radiating upwards and outwards from a central point. Below the sunburst, the word "ATRIX" is printed in a bold, sans-serif font, and beneath that, the words "LABORATORIES, INC" are printed in a smaller, sans-serif font.
PHONE: (970) 482-5868
EMAIL: atrixlab@frii.com http://www.atrixlabs.com
510(k) Summary of Safety and Effectiveness
1. General Information
| Manufacturer: | Atrix Laboratories, Inc.
2579 Midpoint Drive
Fort Collins, CO 80525-4417
Telephone: 970-482-5868
Fax: 970-482-9735 |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Elaine M. Gazdeck, R.A.C.
Vice President, Regulatory Affairs/Quality |
| Device Generic Name: | Bioabsorbable GTR Barrier Kit (used to form a
Bioabsorbable GTR Barrier) |
| Device Trade Name: | ATRISORB® Bioabsorbable Guided Tissue
Regeneration (GTR) Barrier Kit (used to form an
ATRISORB® Bioabsorbable GTR Barrier) |
| 510(k) Clearance Number
for Unmodified Device: | K955838 |
| 510(k) Clearance Number
for Modified Device: | K |
| Date Prepared: | July 1, 1998 |
| Predicate Device: | GORE-TEX® Periodontal Material |
1. Description
1.1. Formulation
The ATRISORB® polymer formulation is a sterile, synthetic flowable polymeric formulation which is bioabsorbable and has been developed for GTR procedures by Atrix Laboratories, Inc. It consists of a polymer of lactic acid, poly(DL-lactide) (PLA), dissolved in N-methyl-2-pyrrolidone (NMP).
1
2.2. Device
The finished device is provided in two different packaging configurations. The first configuration is the ATRISORB® GTR Barner Kit (case kit) used to form either with the barrier-forming case (extraoral) or by direct application over bone grafting material. The second configuration is the ATRISORB® GTR Barrier multipack (multipack) used only for the direct application technique.
The ATRISORB® GTR Barrier Kit configuration contains a foil-pouched, single-patient use dose pack containing 0.5 g of ATRISORB® polymer formulation, a pouched tray that contains a barrier forming case and three units of 0.9% sodium chloride solution (pH range 3.5 - 6.0), and an instructions for use booklet.
The barrier forming case has two sections of porous pads held in the cavities of the case and two spacers that are loose in the case. A label with a 1 mm grid pattern is affixed to the underside of the case. This grid is visible through the case and allows an area on the inside of the case to be used for trimming the formed barrier
The ATRISORB® GTR Barrier multipack configuration consists of three foilpouched, single patient use dose packs containing 0.5 g of the ATRISORB® polymer formulation, three 18 gauge cannulae, and an instructions for use booklet.
3. Mechanics
The ATRISORB® GTR barrier functions as a guided tissue regeneration barrier by isolating the regenerative surgical site from the adjacent gingival connective tissue and epithelium. This facilitates population of the surgical site with cells from the periodontal ligament and adjacent alveolar bone that lead to regeneration.
The ATRISORB® polymer formulation is a flowable solution. A preformed GTR barner, with consistent thickness, is prepared by using a barrier forming kit. The flowable formulation partially precipitates when it is "sandwiched" between two porous pads which are wetted with sodium chloride solution contained in a barrier forming case. The barrier thickness is determined by the thickness of the spacers which hold the two porous pads apart. The barrier, which is prepared in approximately three to six minutes, can be trimmed to the required size and morphology of the defect. The formed ATRISORB® GTR barner is applied to the defect
Another method of forming the barrier can be accomplished in situ where the tissue fluid aids in the precipitation of the barrier at the defect site. For defects where bone replacement graft material has been applied, the flowable formulation can be applied directly over the grafting material. Extraoral formation (formed in the case) is required when grafting materials are not used, as the unprecipitated formulation would flow into the defect.
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With either method of application, the formed barrier is a film which covers the defect. Once in place, it continues to solidify and the resulting barrer precludes the migration of epithelial or connective tissue cells through it, and simultaneously isolates the periodontal compartment, thereby facilitating regeneration. The chemistry of the ATRISORB® polymer formulation is such that, after setting, the polymer component subsequently bioabsorbs through the process of hydrolysis. Bioabsorption occurs over the course of several months. The barrier is present and intact during the critical period when periodontal regenerative cells are proliferating during the wound healing cascade from adjacent periodontal sources.
4. Intended Use
The clinical indications for the ATRISORB® GTR Barrier are for GTR procedures in the surgical treatment of Class II furcations, or 2 and/or 3 walled intra-osseous defects and dehisence defects to aid in the regeneration and integration of periodontal tissue components.
The indications for the ATRISORB® GTR barrier are equivalent to the indications for the predicate device, expanded polytetrafluoroethylene (e-PTFE) GORF-TEX® Periodontal Material (W.L. Gore & Assoc., Flagstaff, AZ).
The indications that differ are for bioabsorbability and elimination of a second surgical procedure to remove a non-bioabsorbable material. Results of preclinical and clinical trials support the claim of bioabsorbability and good tissue compatibility.
The predicate device, GORE-TEX® Periodontal Material, is indicated as an implantable material to aid in the healing of periodontal defects. The GORE-TEX® Periodontal Material is non-bioabsorbable and requires a second surgical procedure to remove it.
5. Summary of In Vitro Studies
5.1. Cytotoxicity
The study evaluated the toxic effects of the ATRISORB® GTR barrier upon mature monolayer tissue cultures of L929 cells. The ATRISORB® GTR barrier is mildly cytotoxic; however, these results are not consistent with results from more meaningful, in vivo implantation and clinical studies on the barrier.
5.2. Sensitization
A guinea pig maximization test, based on the method of Magnusson and Kligman (1970), was used to evaluate the potential of the ATRISORB® polymer formulation to elicit delayed dermal contact sensitization. The ATRISORB® polymer formulation is not a skin sensitizer
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Genotoxicity 5.3.
Genotoxicity
The study evaluated the mutagenicity of an extract of the ATRISORB® The study evaluated the mutagencity of an extract of the mulation is not mutagenic.
polymer formulation. The ATRISORB® polymer formulation is not mutagenic.
Pyrogenicity - Limulus Amebocyte Lysate Test (LAL) 5.4.
Pyrogenicity - Limules Almaded the concentration of bacterial endotoxins in an extract
The LAL test estimated the concentration of bacterial non-The LAL test estimated the concentration of becamer is nonpyrogenic according to this test method.
Hemolysis 5.5.
The ATRISORB® GTR barrier causes hemolysis in an in vitro test system, The ATRISORB® GTR Dannel Causes hemolysis in patients treated with the barrier.
but it is highly unlikely to cause hemolysis in patients begolvice potential using but it is highly unlikely to cause nemorysis nemolytic potential using
The study evaluated the ATRISORR® GTR barner's hemolytic potential using The study evaluated the ATKION City of the Buffering capacity. The barrier
human blood in an in vitro system with the black and the NMP human blood in an in vitro system title blood path and the NMP does not have significant contact with the blood personal.
concentrations in this assay may have been far greater than that which could be attained in the human body.
Based upon this analysis, the ATRISORB® GTR berner's in vitro hemolytic Based upon this analysis, the ATTATCOND of the barrier in accordance with the barrier's intended use.
Sterilization 5.6.
The ATRISORB® GTR Barrier Kit and ATRISORB® GTR Barrier are The ATRISORD® GTK Banier Tat and Arradiation. The cannulae in the terminally sterilized by Costing are provided sterile by the manufacturer and are not further processed.
Bioburden 5.7.
Bioburden determination is performed prior to sterilization following USP procedures.
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6. Summary of In Vivo Implantation Studies
Subchronic Implantation 6.1.
Subchronic implantation
The study evaluated the biocompatibility of the rat . During the course o The study evaluated the blocompanism of the rest. During the course of the when surgically implanted subcularied around any of the test implantation sites study, no toxicity was observed around any of the toot major and the locked to the really was observed
which could be directly related to the barrier. No overt toxicity was which could bing the course of the study.
The subcutaneous implantation of the ATRISORB® GTR barner in rats for a
rt a many and the country to this taxicity The subcatures and not result in toxicity.
Chronic Implantation and Biodegradation 6.2.
Chronic Imprantation and Libers of the ATRISORB® GTRISORB® GTR
The study evaluated (1) the degradation kinetics of the controls The study evaluated (1) the degradation hiriclib the barner The controls for
barrier, and (2) response of tissue in contact with the barner of the test and barrier, and (2) response of tissue in concess winding of the test and
the study were USP plastic strips. Histological examination of the test and the study were USP plastic surpos. This signs of biologically significant
control excised implant sites showed no significant difference between control excised implant sites showed no significant difference between the
changes or abnormal tissue. There was no significant dissue effects. changes or abnormal tissue. There was no significant and control sites .
ATRISORB® GTR barrier sites and control sites with respect to tissue effects.
The study demonstrated that the ATRISORB® GTR barrier does not ellicit The study demonstrated the the ATRIONDO Shipping on rabbits for up
toxicity (dermal or systemic) when subcutaneously implanted in rabbits for up toxicity (dermal or systemic) when subculariously implication of the ATRISORB® GTR barrier should
to twelve months and biodegradation of the ATRISORB® GTR barrier should be complete by 13-14 months.
7. Summary of Animal Efficacy Studies
Histology Study 7.1.
This study compared the safety, clinical results, and histologic effects of This study compared the Sately, cirinour returns in six adult beagle dogs
ATRISORB® GTR barriers to sham operated controls in six adult beagle dogs ATRISORD® GTR Barnors is unam of them on tall furcation defects.
A periodontal surgeon selected and prepared 16 study sites as follows: a full A periodontal surgeon selector and propares was reflected, plaque and thickness ilap created after giftgirds increasing devices, and roots planed by hand. calculus were removed with ultrasonic were applied to eight test sites, all
Preformed ATRISORB® GTR barriers were applied to eight test sites, all Preformed ATRISORD® OTTS Barner . Post-surgery periodontal maintenance
study sites were closed and sutured. Post-surgery periodontal maintenance sites were closed and Sularou. T est only inse to all study sites for consisted on topical applications or shed using a modified Bass technique wo months, then the teen were bradned as a graintegrity, clinical conditions, with brushes soaked in Pendox® crainment of the study. All of the animals were sacrificed after six months of observation.
The ATRISORB® GTR barrier demonstrated clinically and statistically The ATRIONDO OTHe depth, horizontal furcation depth, and improved superior results in position as a more significantly increased the
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amount of periodontal regeneration (i.e., new bone, cementum, and amount of periodontal regeneration (f.e., hew bone, before, before, and toxicity
periodontal ligament formation) in the furcation defect. No signs of toxicity were observed.
Biodegradation and Safety Study 7.2.
Biodegradation and Safety Study
The object of this study was to evaluate the potential for clinical application, The object of this study was to evaluate the potential hor and the polymer
clinical management, safety and biocompatibility of a biodegradable polymer clinical management, salety and blockhpanding or cated to facilitate groend thissue
barrier preformed in a barrier forming device to facilitate in the barrier preformed in a barner forming device to fallance a maxilla in the dog.
regeneration at periodontal defects in the study and 17 naturally occurring defects regeneration at periodontal detects in the study and 17 naturally occurring defects
Seven beagle dogs were used in the study and 17 naturally were treated. Twelve periodontal furcation defects were treated surgically were treated. Twelve pendontal furcation if the barriers formed with three
with ATRISORB® GTR barriers to determine if the bartiers formed with three with ATRISORB® GTR barners to determine if the barners for the world.
prototype kits compared favorably to 5 sham operated controls in terms of
the supers of the company to safety and biocompatibility.
The ATRISORB® GTR barrier was well tolerated in all periodontal test sites
in the ATRISOR was and continues inflammation compared to control The ATRISORB® GTR barner was well tolerated in all por
and produced no increases in localized inflammation compared to control sites.
Use of the ATRISORB® GTR barrier in treating periodontal defects in the dog
ing and the collection birthlaniael evidence of adverse healing and Use of the ATRISORB® GTTA banier in treating for a resulted in no clinical or histological evidence of dover of the end of one vear.
Histological examination confirmed that barriers were completely absorbed at
the examination and confinent and spicule found in one out of twelve Histological examination confilmed that bamore word in one out of twelve
12 months with the exception of one small spicule found in one out of twelve test sites.
Pilot Study 7.3.
Pliot Study
This study was a pilot study designed to examine four compositions of This study was a pilot study designed to oxepare the ATRISORB® GTR ATRISORB® polymer formulation used to propare tissue regeneration in the periodontal region.
Thirty-nine defects were treated in six beagle dogs. All dogs were terminated I hirty-hine defects were treated in six bearier placement. The study
between 9 and 12 months following initial bearier placement, The study between 9 and 12 months lollowing think barner pecome reconstituted on root
showed that new periodontal supporting tissues became reconstituted on root showed that hew penodonial burgically-induced and naturally-occurring and furcation sunasse in ssirg. The ATRISORB® GTR barrier.
Feasibility Study 7.4.
The objective of this study was to evaluate the safety and potential of a The objective of this study was to overse to facilitate periodontal synthetically formulated nowable polymer same to the canine and
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molar regions of dogs over a period of 3 months. Two dogs were used with a moral regions of "dogeier sites and 8 control sites) being treated.
The results of this study demonstrated the potential safety and the ability of l he results of this study demonstration the polymers to facilitate periodontal tissue regeneration.
8. Summary of Pivotal Trial
A pivotal clinical trial under an FDA Investigational Device Exemption was conducted A pivotal cillinear that chuck and efficacy of the ATRISORB® GTR Barrier Kit in a multicenter clinical trial.
The primary object of the study was to demonstrate that the ATRISORB® GTR The primally object of the study was to GRE-TEX® periodontal material for guided tissue regeneration (GTR) treatment of Class II furcation defects in humans. The tissue regeneration (GTTY) a cannertical and horizontal attachment level, with primally clinical end points were vig pocket depth, bleeding on probing, gingival margin location, and gingival index.
The investigation was a multicenter study with a paralled design. Individuals with a The investigation was a mailies national with either ATRISORB® GTR barrier or Glass in furcation delect were troulou with on randomized treatment assignment. OUtcomes of healing were evaluated at regular intervals up to one year after the Outcomes of nealing were comparisons of clinical results between the two products were made in order to demonstrate substantial equivalency between the were made in order to riement GORE-TEX® periodontal material in guided tissue regeneration treating Class II furcation defects.
One hundred sixty-two subjects were randomized and entered into this 52-week one handroo oxly the sabjects are a learner and 80 subjects received GORE-TEX® periodontal material. Subjects were selected if they met the following entry criteria:
- A Class II furcation with vertical pocket depth []5 mm and attachment loss at the site and the horizontal depth of the furcation was 03 mm
- Between the ages of 25 and 75 .
- . in good general health
Radiographs were taken within the two months prior to Screening or at the Screening or Baseline visit, and provided evidence of crestal alveolar bone loss associated with periodontitis.
The study demonstrated that ATRISORB® GTR barner is substantially equivalent to the predicate device, GORE-TEX® periodontal material for the treatment of periodontal defects using guided tissue regeneration procedures.
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The safety results over the 52-week duration of the study support the benign The salety results over the ose of the ATRISORB® GTR barrier.
Summary of the Statistical Analysis of the Data from the Pivotal Clinical 8.1. Trial
The following tabulation presents the data for ATRISORB® GTR barrier vs. GORE-TEX® periodontal material at Baseline and Week 52. Vertical attachment level gain significantly satisfied the condition of clinical attachment level gall regility wo treatment groups at Week 52. The mean equivalence between the the treated with ATRISORB® GTR barner was 0.38 mm greater than the mean for subjects treated with GORE-TEX® periodontal material. The null hypothesis that GORE-TEX® periodontal material was clinically superior by at least 0.5 mm was rejected with a p-value of less than 0.001. The one-sided confidence interval for the difference of less than 0.00 . - TRUSORB® GTR barrier and the GORE-TEX® periodontal between the ATTRICO any difference greater than 0.08 mm in favor of GORE-TEX® periodontal material can be ruled out with 95% confidence.
Horizontal attachment level gain significantly satisfied the condition of clinical equivalence between the two treatment groups at Week 52. The mean increase at Week 52 for subjects treated with ATRISORB® GTR barrier was slightly greater (0.04 mm) than the mean for subjects treated with GORE-TEX® periodontal material. The null hypothesis that GORE-TEX® periodontal material was clinically superior by at least 0.5 mm was rejected with a p-value of 0.017. The one-sided confidence interval for the difference in treatment effects indicates that any difference greater than 0.38 mm can be ruled out with 95% confidence.
Pocket depth improvement significantly satisfied the condition of clinical equivalence for the two treatment groups at Week 52. The mean decrease at Week 52 was 0.18 mm greater for ATRISORB® GTR barrier subjects than the mean decrease for subjects treated with GORE-TEX® periodontal material.
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| Measurement | Time Point | ATRISORB® GTR Barrier | GORE-TEX® Periodontal Material | GORE-TEX® Periodontal Material Minus ATRISORB® GTR Barrier Difference | P-value* | One-sided* Confidence Interval | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean | S.E. | N | Mean | S.E. | |||||
| Vertical Attachment Level | Baseline** | |||||||||
| Week 52 | 76 | 5.82 | 0.21 | 73 | 5.74 | 0.20 | -0.08 | 0.009 | 0.30 | |
| 66 | 2.00 | 0.19 | 64 | 1.63 | 0.20 | -0.38 |