A Comparative Clinical Study Between a Collagen Matrix and Collagen Membrane as Wound Protection During Ridge Preservation ARP

NCT06029322 | Active Not Recruiting DMC

• 1 other identifier: ONZ-2023-0516
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in need of extraction of two teeth in combination with alveolar ridge preservation will be invited to participate in intra-subject RCT on ARP. Prior to surgery, a small-field low-dose CBCT is taken. 18 patients will be included, each contributing 1 surgical site to each treatment arm. Since this study is a intra-subject RCT randomization of the surgical site will be performed just after ARP by a coin flip. Randomization is concealed for the evaluating examiner and statistician. After ARP the collagen matrix or collagen membrane is used to seal the coronal aspect of the extraction socket. Soft tissue thickness in centre of the site will be determined using CBCT. Secondary outcomes include: Wound dimensions, socket wound healing score, changes in bone and soft tissue dimensions and changes in buccal soft tissue profile

Conditions

Oral Soft Tissue Conditions

Keywords

collagen matrix; collagen membrane; alveolar ridge preservation (ARP); CBCT analysis; Volumetric analysis; peri-implant health; oral implant

Outcome Measures

Primary Outcomes (1)

• Soft tissue thickness in the centre of the site

  Changes in the soft tissue thickness at the centre of the site measured on CBCT

  pre-op, 4 months

Secondary Outcomes (3)

• Socket Wound Healing Score (SWHS)

  1 week, 3 weeks, 4 months

• Changes in bone and soft tissue dimensions

  4 months

• Changes in buccal soft tissue profile

  pre-op, 4 months

Study Arms (2)

Collagen membrane

ACTIVE COMPARATOR

BioGide Compressed® 13x25 mm, Geistlich Pharma AG, Wolhusen, Switzerland

Procedure: Socket seal after alveolar ridge preservation

collagen matrix

EXPERIMENTAL

Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland

Procedure: Socket seal after alveolar ridge preservation

Interventions

Socket seal after alveolar ridge preservation PROCEDURE

Socket seal is performed after ARP. Using a collagen matrix or membrane the socket is sealed, at the control (membrane) site a small pouch is made at the buccal and lingual aspect. Monofilament sutures are used to secure the respective material in place.

Collagen membrane; collagen matrix

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years old
• Good oral hygiene defined as a full-mouth plaque score ≤ 25% (O'Leary, Drake, \& Naylor, 1972)
• Need for ARP after tooth extraction at two sites in the maxilla or mandible with \> 50% buccal bone present following tooth extraction
• Signed informed consent

You may not qualify if:

• Any systemic disease
• Pregnancy
• Smoking (will be specifically asked)
• Untreated periodontitis
• Untreated caries lesions
• Suppuration and/or active infection around the failing tooth
• Midfacial recession at the failing tooth

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

Related Publications (7)

• Afat IM, Akdogan ET, Gonul O. Effects of leukocyte- and platelet-rich fibrin alone and combined with hyaluronic acid on early soft tissue healing after surgical extraction of impacted mandibular third molars: A prospective clinical study. J Craniomaxillofac Surg. 2019 Feb;47(2):280-286. doi: 10.1016/j.jcms.2018.11.023. Epub 2018 Dec 3.

  PMID: 30579747 BACKGROUND

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

• Eeckhout C, Bouckaert E, Verleyen D, De Bruyckere T, Cosyn J. A 3-Year Prospective Study on a Porcine-Derived Acellular Collagen Matrix to Re-Establish Convexity at the Buccal Aspect of Single Implants in the Molar Area: A Volumetric Analysis. J Clin Med. 2020 May 22;9(5):1568. doi: 10.3390/jcm9051568.

  PMID: 32455863 BACKGROUND

• Martins JR, Wagner TP, Vallim AC, Konflanz W, Schwendicke F, Celeste RK, Haas AN. Comparison of the efficacy of different techniques to seal the alveolus during alveolar ridge preservation: Meta-regression and network meta-analysis. J Clin Periodontol. 2022 Jul;49(7):694-705. doi: 10.1111/jcpe.13628. Epub 2022 Apr 29.

  PMID: 35451071 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

• Seyssens L, Eghbali A, Christiaens V, De Bruyckere T, Doornewaard R, Cosyn J. A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis. Clin Implant Dent Relat Res. 2019 Oct;21(5):853-861. doi: 10.1111/cid.12843. Epub 2019 Aug 28.

  PMID: 31456345 BACKGROUND

• Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.

  PMID: 27978602 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It concerns a surgical intervention. Hence, the treating surgeon and patient cannot be masked. The investigators and outcome assessors are masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design, intra-subject RCT Patients receive both treatments: collagen matrix and collagen membranes

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: January 2, 2024
• Primary Completion: August 2, 2025
• Study Completion: December 2, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

BE (1)