Efficacy of Collagen Matrix for Peri-implant Soft Tissue Phenotype Modification

NCT07056959 | Recruiting

• 1 other identifier: MBRU-HBMCDM-RG2025-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A stable band of keratinized mucosa (KM) around dental implants is thought to minimize tissue recession and provide resistance against mechanical, chemical, and microbial challenges, thereby preserving peri-implant tissue health. Soft tissue augmentation is often employed to enhance the soft tissue phenotype in such cases. While autogenous grafts such as free gingival grafts (FGG) remain the gold standard, xenogeneic collagen matrices (XCM) have emerged as promising alternatives, offering reduced patient morbidity and surgical time. This randomized controlled clinical trial aims to compare the clinical efficacy and patient-reported outcome measures (PROMs) of XCM versus FGG for soft tissue phenotype modification when performed during healing abutment connection around dental implants, with evaluations at both short-term (6 months) and long-term (1 and 2 years) intervals. Thirty participants will be recruited at Dubai Health Dental Hospital and randomly assigned to receive either XCM (test) or FGG (control) augmentation. Clinical assessments will be conducted at baseline (T0), 2 weeks (T2w), and at 1 (T1), 3 (T3), 6 (T6), 12 (T12), and 24 (T24) months post-surgery. The primary outcome is the change in KM width, measured from the mucosal margin to the mucogingival junction. Secondary outcomes include KM thickness, supracrestal tissue height, and soft tissue dimensional changes, assessed using intraoral scans (Trios 5) and superimposed STL files. Additional measurements include peri-implant soft tissue level and phenotype. PROMs will be recorded in the first postoperative week and at the 3-year mark using a visual analog scale (VAS). Clinical indices such as plaque index, bleeding index, and probing depth will be evaluated at 6 months, 1 year, and 2 years. Marginal bone level changes and implant survival rates will also be tracked throughout the study period.

Conditions

Keratinized Mucosa; Keratinized Tissue

Keywords

keratinized mucosa; implants; soft tissue augmentation

Outcome Measures

Primary Outcomes (1)

• Changes in Keratinized Mucosa width

  Changes in KM width - as measured from the free mucosal margin to the mucogingival junction at the mid-buccal aspect of the implant abutment or crown with a UNC-15 probe; at the follow-up time point relative to the baseline at T0

  6 months

Secondary Outcomes (1)

• Changes in KM thickness and supracrestal tissue height

  6 months

Other Outcomes (1)

• Patient reported outcome measures (PROMs)

  6 months

Study Arms (2)

Test group - Mucograft

EXPERIMENTAL

XCM (Mucograft©, Geistlich Pharma® AG, Wolhusen, Switzerland) when placed at the time of healing abutment connection and its impact on peri-implant soft tissue phenotype modification

Procedure: Soft tissue substitute for peri-implant phenotype modification

Control Group - Free gingival graft

ACTIVE COMPARATOR

Use of Free gingival graft placed at the time of healing abutment connection and its impact on peri-implant soft tissue phenotype modification

Procedure: Control Group - Free gingival graft for soft tissue augmentation

Interventions

Soft tissue substitute for peri-implant phenotype modification PROCEDURE

XCM (Mucograft©, Geistlich Pharma® AG, Wolhusen, Switzerland) placed at the time of healing abutment connection and its impact on peri-implant soft tissue phenotype modification when

Test group - Mucograft

Control Group - Free gingival graft for soft tissue augmentation PROCEDURE

Free gingival graft around implants placed at the time of healing abutment connection and its impact on peri-implant soft tissue phenotype modification

Control Group - Free gingival graft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 or over.
• Insufficient KM width (\< 2 mm) at the buccal aspect of implants at time of healing abutment placement, either for single anterior or posterior implants.
• Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

You may not qualify if:

• Smoking
• Untreated localized or generalized periodontal diseases
• Uncontrolled systemic diseases
• Long term use of non-steroidal anti-inflammatory medications
• History of malignancy, radiotherapy or chemotherapy
• Collagen allergy
• History of mucogingival surgery

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

Dubai Dental Hospital

Dubai, United Arab Emirates

RECRUITING

Related Publications (3)

• Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12.

  PMID: 19678861 RESULT

• Naenni N, Bienz SP, Benic GI, Jung RE, Hammerle CHF, Thoma DS. Volumetric and linear changes at dental implants following grafting with volume-stable three-dimensional collagen matrices or autogenous connective tissue grafts: 6-month data. Clin Oral Investig. 2018 Apr;22(3):1185-1195. doi: 10.1007/s00784-017-2210-3. Epub 2017 Sep 18.

  PMID: 28924826 RESULT

• Cosyn J, Eeckhout C, De Bruyckere T, Eghbali A, Vervaeke S, Younes F, Christiaens V. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 1-year results. J Clin Periodontol. 2022 Sep;49(9):911-921. doi: 10.1111/jcpe.13691. Epub 2022 Jul 20.

  PMID: 35781692 RESULT

Central Study Contacts

Maanas shah, BDS MSD CAGS MRACDS

CONTACT

971556102178; maanas.shah@dubaihealth.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-06

Locations

AE (1)