N/A
N=4
Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration
Periodontal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03095976 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Probing Depth Change — 4.22 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amnion-Chorion allograft membrane on the root surface of periodontally diseased site. (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probing Depth Change |
4.22 | — |
| PRIMARY Clinical Attachment Change |
2.44 | — |
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.
Eligibility Criteria
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;
- Glickman Grade II furcation involvement on buccal of mandibular or maxillary first or second molars without soft tissue exposure of furcation entrance; 7) tooth mobility Miller Grade <1; 8) more than 2mm of keratinized tissue with those selected teeth.
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.
Data sourced from ClinicalTrials.gov (NCT03095976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.