Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites

Not Applicable

Active, not recruiting

• Conditions: Surgery

• Registration Number: NCT05844475
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief Summary

The study aims at comparing two different approaches for soft tissue augmentation at implants lacking keratinized and adherent mucosa width: the free gingival graft (FGG) vs the Buccal Strip Graft in combination with a xenogeneic collagen matrix (BSG + CM)

Detailed Description

Conventional free gingival graft (FGG), serving as control group, will be compared to buccal strip gingival graft (BSG) in combination with a collagen matrix (CM), serving as test group, in terms of clinical, volumetric, ultrasonographic, and patient-reported outcomes related to soft tissue augmentation at implant sites lacking keratinized and adherent mucosa.

Study Timeline

• Study First Submitted: 2023-04-05
• Study Start: 2023-04-13
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09-21
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Age ≥ 18 years,
• Periodontally and systemically healthy,
• Full-mouth plaque score and full-mouth bleeding ≤ 20% (measured at four sites per tooth),
• Presence of at least one dental implant with < 2 mm of KM and lack of firm/adherent mucosa,
• Presence of at least 4 mm of keratinized gingiva in two or more teeth nonadjacent to the implant to be treated,
• Implants diagnosed as healthy (Berglundh et al. 2018),
• The patient must be able to perform good oral hygiene.

Exclusion criteria:

• Contraindications for surgery,
• Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
• Patients pregnant or attempting to get pregnant (self-reported),
• Untreated periodontitis,
• Untreated peri-implant mucositis or peri-implantitis (Berglundh et al. 2018),
• Smoking,
• Allergy to collagen-based medical products or iodine,
• Previous free gingival graft procedure at the target site.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sites showing KM≥ 2 mm and AM≥ 1 mm	6 and 12 months	Number of sites showing at least 2 mm of keratinized mucosa width (in millimeters) and at least of 1 mm of attached mucosa (in millimeters) (outcome expressed as a number)

Secondary Outcome Measures

Name	Time	Method
Volumetric change	6 and 12 months	Volumetric change occurring at the treated sites analyzed by superimposing digital impressions obtained using optical scanners at baseline and 6 months (expressed in mm\^3)
KM width gain	6 and 12 months	Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Esthetic assessment	Baseline and 12 months	Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the initial and last visit (expressed as a number)
Post-operative morbidity	Daily, for the first 4 weeks after the procedure	Patient-reported outcome assessed using a daily questionnaire first the first 4 weeks (expressed as a number using a 0-100 visual analogue scale \[VAS\])
Ultrasonographic strain elastography	Baseline, 3 months, 6 months and 12 months	Changes in the elasticity of the soft tissue over the healing assessed with ultrasonography (expressed as a ratio)
AM gain	6 and 12 months	Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Ultrasonographic tissue perfusion	Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months	Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s)
Treatment satisfaction	12 months	Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number)
Mucosal thickness (MT) gain	6 and 12 months	Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters)

Trial Locations

Locations (1)

Harvard School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States