SurgeryFGGvsBSG+CMNCT05844475
Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites
A study testing Conventional Free Gingival Graft Approach (FGG) and Buccal Strip Graft with a collagen matrix (bSG + CM) in people with Surgery, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Conventional Free Gingival Graft Approach (FGG) and Buccal Strip Graft with a collagen matrix (bSG + CM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
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
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)
Read the 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.
- Conditions
- Surgery
- Being tested
- Conventional Free Gingival Graft Approach (FGG), Buccal Strip Graft with a collagen matrix (bSG + CM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Free Gingival Graft Approach (FGG)Procedure or surgery
Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting
Buccal Strip Graft with a collagen matrix (bSG + CM)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Buccal Strip Graft with a collagen matrix (bSG + CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 and 12 months
Secondary outcomes (9)
KM width gain
Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Measured: 6 and 12 months
AM gain
Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Measured: 6 and 12 months
Mucosal thickness (MT) gain
Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters)
Measured: 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)
Measured: 6 and 12 months
Ultrasonographic tissue perfusion
Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s)
Measured: 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])
Measured: Daily, for the first 4 weeks after the procedure
Treatment satisfaction
Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number)
Measured: 12 months
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)
Measured: Baseline and 12 months
Ultrasonographic strain elastography
Changes in the elasticity of the soft tissue over the healing assessed with ultrasonography (expressed as a ratio)
Measured: Baseline, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Apr 2023
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Principal investigator, Lorenzo Tavelli, Harvard Medical School (HMS and HSDM)
- Investigators
- Lorenzo Tavelli, DDS, MS, PhD, Principal investigator, Harvard School of Dental Medicine, Boston, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844475
- Sponsor's protocol ID
- IRB23-0131
- Acronym
- FGGvsBSG+CM
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844475
- Acronym / sponsor ID
- FGGvsBSG+CM / IRB23-0131
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft (FGG) | Active comparator | Procedure: Conventional Free Gingival Graft Approach (FGG)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). |
| Buccal Strip Graft + Collagen matrix (bSG + CM) | Experimental | Procedure: Buccal Strip Graft with a collagen matrix (bSG + CM)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Free Gingival Graft Approach (FGG)Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting | Procedure or surgery | Free gingival graft (FGG) |
| 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 | Procedure or surgery | Buccal Strip Graft + Collagen matrix (bSG + CM) |
Primary outcome
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)
9 secondary outcomes
KM width gain
Time frame: 6 and 12 months
AM gain
Time frame: 6 and 12 months
Mucosal thickness (MT) gain
Time frame: 6 and 12 months
Volumetric change
Time frame: 6 and 12 months
Ultrasonographic tissue perfusion
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months
Post-operative morbidity
Time frame: Daily, for the first 4 weeks after the procedure
Treatment satisfaction
Time frame: 12 months
Esthetic assessment
Time frame: Baseline and 12 months
Ultrasonographic strain elastography
Time frame: Baseline, 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Tavelli, DDS, MS, PhD principal investigator
Harvard School of Dental Medicine, Boston, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Free Gingival Graft Approach (FGG) and Buccal Strip Graft with a collagen matrix (bSG + CM) in people with Surgery, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sites showing KM≥ 2 mm and AM≥ 1 mm (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.