Effect of Collagen Membrane on Ridge Preservation

NCT07580495 | Recruiting FDA Device

• 1 other identifier: STUDY25080006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement. Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans. The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.

Conditions

Dehiscence; Tooth Extraction; Alveolar Bone Loss

Keywords

Ridge preservation; Collagen membrane; Socket grafting; Buccal bone loss; Delayed implant placement

Outcome Measures

Primary Outcomes (1)

• Horizontal dimensional changes (%)

  Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.

  Baseline and 4 months

Secondary Outcomes (15)

• Horizontal dimensional changes (%)

  Baseline and 4 months

• Horizontal dimensional changes (%)

  Baseline and 4 months

• Vertical dimensional changes (%)

  Baseline and 4 months

• Vertical dimensional changes (%)

  Baseline and 4 months

• Volumetric dimensional changes (%)

  Baseline and 4 months

Study Arms (2)

Control group (bone graft only)

ACTIVE COMPARATOR

Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.

Procedure: Minimally Invasive tooth extraction; Device: Alveolar ridge preservation with ABCC

Test group (bone graft + collagen membrane)

EXPERIMENTAL

Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.

Procedure: Minimally Invasive tooth extraction; Device: Alveolar ridge preservation with ABCC; Device: Resorbable collagen membrane (InterCollagen® Guide)

Interventions

Minimally Invasive tooth extraction PROCEDURE

Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.

Control group (bone graft only); Test group (bone graft + collagen membrane)

Alveolar ridge preservation with ABCC DEVICE

The extraction socket will be grafted with ABCC (SigmaGraft®).

Control group (bone graft only); Test group (bone graft + collagen membrane)

Resorbable collagen membrane (InterCollagen® Guide) DEVICE

A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.

Test group (bone graft + collagen membrane)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80
• Indicated for extraction of a single-rooted maxillary tooth
• ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
• Presence of both adjacent teeth
• No interproximal bone loss
• ASA I-II health status
• Ability to comply with required procedures, including attending required number of clinic visits

You may not qualify if:

• Patients diagnosed with periodontitis adjacent to the area to be treated
• History of allergic reactions to local anesthetics or bone graft material (self-reported);
• Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
• Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
• Presence of active infectious diseases of any kind;
• History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
• Severe hematologic disorders (risk for hemorrhage)(self-reported);
• Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
• Any history of alcohol or drug abuse (self-reported);
• Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);

Sponsors & Collaborators

• Debora Dias: lead
• SigmaGraft Inc.: collaborator

Study Sites (1)

University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (9)

• Hutton CG, Johnson GK, Barwacz CA, Allareddy V, Avila-Ortiz G. Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):807-814. doi: 10.1002/JPER.17-0597. Epub 2018 Jul 20.

  PMID: 29633268 BACKGROUND

• Natto ZS, Parashis A, Steffensen B, Ganguly R, Finkelman MD, Jeong YN. Efficacy of collagen matrix seal and collagen sponge on ridge preservation in combination with bone allograft: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jun;44(6):649-659. doi: 10.1111/jcpe.12722. Epub 2017 May 26.

  PMID: 28303642 RESULT

• Tonetti MS, Sanz M, Avila-Ortiz G, Berglundh T, Cairo F, Derks J, Figuero E, Graziani F, Guerra F, Heitz-Mayfield L, Jung RE, Lai H, Needleman I, Papapanou PN, Sailer I, Sanz-Sanchez I, Schwarz F, Shi J, Thoma D. Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report. J Clin Periodontol. 2023 May;50 Suppl 25:5-21. doi: 10.1111/jcpe.13808. Epub 2023 May 4.

  PMID: 37143289 RESULT

• Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized 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. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.

  PMID: 27310522 RESULT

• Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.

  PMID: 22211304 RESULT

• Barone A, Toti P, Quaranta A, Alfonsi F, Cucchi A, Calvo-Guirado JL, Negri B, Di Felice R, Covani U. Volumetric analysis of remodelling pattern after ridge preservation comparing use of two types of xenografts. A multicentre randomized clinical trial. Clin Oral Implants Res. 2016 Nov;27(11):e105-e115. doi: 10.1111/clr.12572. Epub 2015 Feb 26.

  PMID: 25727443 RESULT

• Avila-Ortiz G, Couso-Queiruga E, Stuhr S, Chambrone L. Long-term outcomes of post-extraction alveolar ridge preservation and alveolar ridge reconstruction followed by delayed implant placement: A systematic review. Periodontol 2000. 2025 Jul 3. doi: 10.1111/prd.12642. Online ahead of print.

  PMID: 40605823 RESULT

• Araujo MG, Dias DR, Matarazzo F. Anatomical characteristics of the alveolar process and basal bone that have an effect on socket healing. Periodontol 2000. 2023 Oct;93(1):277-288. doi: 10.1111/prd.12506. Epub 2023 Aug 2.

  PMID: 37533162 RESULT

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Debora R Dias, DDS, PhD

  University of Pittsburgh, Department of Periodontics and Preventive Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debora R Dias, DDS, PhD

CONTACT

4126488595; deboradias@pitt.edu

Carla Sanchez, MS

CONTACT

4126241179; cab28@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to the clinical examiner, the radiographic assessor, and the histological analyst, all of whom will remain unaware of group allocation throughout the study. Due to the nature of the surgical procedures, blinding of participants and surgeons is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 12, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)