NCT05844475

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

April 5, 2023

Last Update Submit

April 8, 2025

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • KM width gain

    6 and 12 months

  • AM gain

    6 and 12 months

  • Mucosal thickness (MT) gain

    6 and 12 months

  • Volumetric change

    6 and 12 months

  • Ultrasonographic tissue perfusion

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

  • +4 more secondary outcomes

Study Arms (2)

Free gingival graft (FGG)

ACTIVE COMPARATOR

Conventional free gingival graft, involving the harvesting of an epithelialized graft from the hard palate, which is then stabilized/sutured to the recipient site (implant).

Procedure: Conventional Free Gingival Graft Approach (FGG)

Buccal Strip Graft + Collagen matrix (bSG + CM)

EXPERIMENTAL

Strip graft obtained from the buccal mucosa of a site showing abundant keratinized gingiva, combined with a collagen matrix. The bSG + CM graft is stabilized/sutured to the recipient site (implant).

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

Interventions

Conventional Free Gingival Graft Approach (FGG)PROCEDURE

Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting

Free gingival graft (FGG)
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

Buccal Strip Graft + Collagen matrix (bSG + CM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Lorenzo Tavelli, DDS, MS, PhD

    Harvard School of Dental Medicine, Boston, USA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 6, 2023

Study Start

April 13, 2023

Primary Completion

September 21, 2025

Study Completion

December 21, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)