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/28303642/Actively Recruiting
Led by Debora Dias · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effect of Collagen Membrane on Ridge Preservation
D
Debora R Dias, DDS, PhD
C
Carla Sanchez, MS
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Debora Dias
Lead Sponsor
SigmaGraft Inc.
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Bone graft (ABCC) with resorbable collagen membrane (InterCollagen® Guide) | Bone graft (ABCC) placed after minimally invasive extraction |
|---|---|---|
| What it is | After minimally invasive extraction, the socket is grafted with particulate bone and then covered with a resorbable collagen membrane (InterCollagen® Guide) positioned in a buccal tunnel. | A socket is filled with particulate bone graft material (ABCC) immediately after minimally invasive tooth extraction. No membrane is used to cover the graft. |
| Role in the trial | Evaluates if adding a resorbable collagen membrane yields better ridge preservation or soft tissue outcomes than bone graft alone. | Serves as the standard care control group to compare effects on bone and soft tissue healing after tooth extraction with dehiscence. |
| Primary use | Intended to further preserve ridge dimensions and soft tissue by using a barrier membrane over the graft. | To limit horizontal and vertical bone loss after extraction by grafting the socket. |
| How it is given or performed | The same flapless extraction and cleansing are followed, with ABCC bone graft placed, then a resorbable collagen membrane (InterCollagen® Guide) is positioned in a buccal tunnel to cover and stabilize the graft. | A minimally invasive, flapless extraction is performed. The socket is cleansed and filled with ABCC bone graft. No covering membrane is placed. |
| Evidence status | External clinical trials show adding a resorbable collagen membrane to a bone graft may better preserve ridge dimensions and improve soft tissue outcomes versus graft alone. | Supported by multiple randomized trials and reviews; reduces bone loss compared to extraction alone but does not fully prevent post-extraction resorption. |
| Important limitations | Requires additional surgical manipulation to place the membrane. May increase procedure cost or time. Not all patients receive added benefit, and optimal protocols for severe dehiscence are still under investigation. | Graft-alone approaches still result in some dimensional bone loss. Technique sensitivity and variability in outcomes are reported. May not fully restore ideal conditions for all implant placements. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/40605823/Debora Dias
Lead Sponsor
SigmaGraft Inc.
Collaborating Sponsor