Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial.
Christopher G Hutton, Georgia K Johnson, Christopher A Barwacz...
https://pubmed.ncbi.nlm.nih.gov/29633268Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07580495
Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial
Led by Debora Dias · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Debora Dias
Lead Sponsor
S
SigmaGraft Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves the preservation of jawbone shape and volume after tooth extraction, which is important for future dental implant placement. This randomized controlled trial compares two approaches in adults needing extraction of a single-rooted maxillary tooth with significant buccal bone loss. The study aims to assess healing outcomes and patient satisfaction over a four-month period. Participants will be randomly assigned to one of two groups: one receiving the ABCC graft alone covered by a collagen sponge, and the other receiving the ABCC graft combined with a resorbable collagen membrane placed in a buccal pouch alongside the graft. Both groups will have similar minimally invasive tooth extraction and follow-up care. The collagen membrane is used to replace missing buccal bone and contain the graft material. During the study, participants will undergo three-dimensional cone beam computed tomography (CBCT) scans, digital intraoral scans, and clinical evaluations to measure changes in bone and soft tissue. Healing will be monitored for complications like wound issues or infections, and patient-reported outcomes such as pain and satisfaction will be collected. In some participants, bone samples will be analyzed at implant placement to study bone healing. The study will determine if treatment allows implant placement without additional bone grafting, with total evaluation lasting about four months.
CONDITIONS
Brief Title
Effect of Collagen Membrane on Ridge Preservation
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18-80 years
- Need extraction of a single-rooted maxillary tooth
- At least 50% buccal bone loss confirmed by CBCT imaging
- Presence of both adjacent teeth
- No interproximal bone loss
- ASA I-II health status
- Ability to attend all required clinic visits and follow procedures
You will not qualify if you...
- Periodontitis near the treatment area
- Allergic reactions to local anesthetics or bone graft materials
- Current heavy smokers (10 or more cigarettes per day) or recent quitters (within 6 months)
- Diagnosis of diabetes mellitus, liver failure, or kidney failure
- Active infectious diseases
- Chemotherapy or radiation to head/neck in past 5 years
- Severe blood disorders increasing bleeding risk
- Use of corticosteroids, intravenous bisphosphonates, or immunosuppressive drugs
- History of alcohol or drug abuse
- Pregnancy or plans to become pregnant within 4 months of enrollment
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 4 months
Participants undergo tooth extraction followed by alveolar ridge preservation with either bone graft alone or bone graft combined with a resorbable collagen membrane. The socket is covered with a collagen sponge secured with sutures without attempting primary closure.
1 treatment visit (in-person) and follow-up visits at 1 week, 2 weeks, and 1 month
Post-treatment Evaluation and Implant Placement
Duration - 1 day
After the healing period, participants return for dental implant placement. Bone and soft tissue healing are assessed through clinical measurements and imaging. Some participants may have a small bone sample collected at implant placement.
1 visit (in-person)
Follow-up Monitoring
Duration - Up to 4 months post-treatment
Participants are monitored for wound healing, complications, pain, quality of life, and satisfaction up to 4 months after treatment.
Visits at 2 weeks and 4 months post-treatment
Trial Site Locations
Total: 1 location
1
University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
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Research Team
D
Debora R Dias, DDS, PhD
C
Carla Sanchez, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy of collagen matrix seal and collagen sponge on ridge preservation in combination with bone allograft: A randomized controlled clinical trial.
Zuhair S Natto, Andreas Parashis, Bjorn Steffensen...
https://pubmed.ncbi.nlm.nih.gov/28303642Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.
Maurizio S Tonetti, Mariano Sanz, Gustavo Avila-Ortiz...
https://pubmed.ncbi.nlm.nih.gov/37143289Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites.
Daniel S Thoma, Marco Zeltner, Monika Hilbe...
https://pubmed.ncbi.nlm.nih.gov/27310522Surgical protocols for ridge preservation after tooth extraction. A systematic review.
Fabio Vignoletti, Paula Matesanz, Daniel Rodrigo...
https://pubmed.ncbi.nlm.nih.gov/22211304Volumetric analysis of remodelling pattern after ridge preservation comparing use of two types of xenografts. A multicentre randomized clinical trial.
Antonio Barone, Paolo Toti, Alessandro Quaranta...
https://pubmed.ncbi.nlm.nih.gov/25727443Long-term outcomes of post-extraction alveolar ridge preservation and alveolar ridge reconstruction followed by delayed implant placement: A systematic review.
G Avila-Ortiz, E Couso-Queiruga, S Stuhr...
https://pubmed.ncbi.nlm.nih.gov/40605823Anatomical characteristics of the alveolar process and basal bone that have an effect on socket healing.
Maurício G Araújo, Debora R Dias, Flavia Matarazzo
https://pubmed.ncbi.nlm.nih.gov/37533162Dimensional ridge alterations following tooth extraction. An experimental study in the dog.
Mauricio G Araújo, Jan Lindhe
https://pubmed.ncbi.nlm.nih.gov/15691354