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

Surgery Clinical Trial

— FGGvsBSG+CM  

Official title:

Buccal Strip Gingival Graft With a Xenogeneic Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites: A Randomized, Controlled, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844475
• Other study ID #: IRB23-0131
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: December 21, 2025

Study information

• Verified date: January 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: Lorenzo Tavelli, DDS, MS, PhD
• Phone: 734-604-4364
• Email: lorenzo_tavelli[@]hsdm.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 21, 2025
• Est. primary completion date: December 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• Conventional Free Gingival Graft Approach (FGG)
Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting
• Buccal Strip Graft with a collagen matrix (bSG + CM)
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

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)	Osteology Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 and 12 months
Secondary	KM width gain	Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters)	6 and 12 months
Secondary	AM gain	Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters)	6 and 12 months
Secondary	Mucosal thickness (MT) gain	Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters)	6 and 12 months
Secondary	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)	6 and 12 months
Secondary	Ultrasonographic tissue perfusion	Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s)	Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months
Secondary	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])	Daily, for the first 4 weeks after the procedure
Secondary	Treatment satisfaction	Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number)	12 months
Secondary	Esthetic assessment	Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the initial and last visit (expressed as a number)	Baseline and 12 months
Secondary	Ultrasonographic strain elastography	Changes in the elasticity of the soft tissue over the healing assessed with ultrasonography (expressed as a ratio)	Baseline, 3 months, 6 months and 12 months