CompletedNot Applicable

Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration

United States4 participantsStarted 2017-06-14

Plain-language summary

The purpose of this pilot project is to evaluate the efficacy of application of Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in conjunction with bone substitute covered by Amnion-Chorion allograft in a combination Guided Tissue Regeneration (GTR) treatment of periodontal intrabony and furcation defects.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. ASA class I or II;
✓. age \>18 years old;
✓. Non-smoker;
✓. diagnosis of chronic or aggressive periodontitis previously treated with nonsurgical mechanical debridement; 5) patients have at least one two-wall intrabony defect in interproximal areas with radiographic evidence of an intrabony component of ≥ 4 mm, PPD ≥ 6 mm with 1-wall or 2-wall or combination of those defects;

Exclusion criteria

✕. did not meet all inclusion criteria;
✕. pregnancy or nursing woman;
✕. subjects with active systemic or localized infection (exclude chronic periodontitis);
✕. poor compliance or failure to maintain good oral hygiene as ascertained by the presence of full-mouth plaque score ≥ 20%;
✕. restorations or caries on root surfaces or untreated endodontic infections;
✕. participants received periodontal surgical treatment on the same site of this study within 2 years;
✕. use of systemic or local antibiotics on the anticipated surgical sites during the past 3 months.

What they're measuring

Probing Depth Change

Timeframe: Baseline and 6 months

Clinical Attachment Change

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT03095976

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-10

Results submitted2021-02-27

View on ClinicalTrials.gov More Periodontal Diseases trials