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NCT Number: NCT05844475

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

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)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Sites showing KM≥ 2 mm and AM≥ 1 mm

    Time frame: 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 outcomes

  1. KM width gain

    Time frame: 6 and 12 months

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

  2. AM gain

    Time frame: 6 and 12 months

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

  3. Mucosal thickness (MT) gain

    Time frame: 6 and 12 months

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

  4. Volumetric change

    Time frame: 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)

  5. Ultrasonographic tissue perfusion

    Time frame: 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)

  6. Post-operative morbidity

    Time frame: 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])

  7. Treatment satisfaction

    Time frame: 12 months

    Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number)

  8. Esthetic assessment

    Time frame: 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)

  9. Ultrasonographic strain elastography

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

  • Osteology Foundation

Registry information

Official study 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

Acronym: FGGvsBSG+CM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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