Surgery
Conditions
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)
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.
Interventions
PROCEDUREConventional Free Gingival Graft Approach (FGG)
Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting
PROCEDUREBuccal 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
Sponsors
Osteology Foundation
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sites showing KM≥ 2 mm and AM≥ 1 mm | 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
| Measure | Time frame | Description |
|---|---|---|
| AM gain | 6 and 12 months | Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters) |
| Mucosal thickness (MT) gain | 6 and 12 months | Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters) |
| Volumetric change | 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) |
| Ultrasonographic tissue perfusion | 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) |
| KM width gain | 6 and 12 months | Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters) |
| Treatment satisfaction | 12 months | Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number) |
| Esthetic assessment | 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) |
| Ultrasonographic strain elastography | 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) |
| Post-operative morbidity | 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 \[VAS\]) |
Countries
United States
Outcome results
None listed