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

N/AActive Not RecruitingNCT05844475

Harvard Medical School (HMS and HSDM)32 enrolled

Overview

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)

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Surgery

Interventions

Conventional Free Gingival Graft Approach (FGG)PROCEDURE

Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting

Buccal Strip Graft with a collagen matrix (bSG + CM)PROCEDURE

A small strip of keratinized gingiva is harvested from the buccal gingiva of a site showing abundant keratinized gingiva, and combined with a xenogeneic collagen matrix

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Sites showing KM≥ 2 mm and AM≥ 1 mm

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)

Time frame: 6 and 12 months

Secondary Outcomes

KM width gain

Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters)

Time frame: 6 and 12 months

AM gain

Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters)

Time frame: 6 and 12 months

Mucosal thickness (MT) gain

Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters)

Time frame: 6 and 12 months

Volumetric change

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)

Time frame: 6 and 12 months

Ultrasonographic tissue perfusion

Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s)

Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months

Post-operative morbidity

Patient-reported outcome assessed using a daily questionnaire first the first 4 weeks (expressed as a number using a 0-100 visual analogue scale \[VAS\])

Data from ClinicalTrials.gov

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