Implant Complication
Conditions
Brief summary
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
Detailed description
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.
Interventions
OTHERProsthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
OTHERProsthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
Sponsors
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel-arm
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 score ≤ 20% (measured at four sites per tooth), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition, * Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018), * Ability 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, defined as self-reported daily habit. Occasional smokers won't be excluded, * History of soft tissue grafting at the implant site showing PSTD within the last 6 months. Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue dehiscence reduction | 6 and 12 months | Reduction of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) compared to baseline (expressed in millimeters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean peri-implant soft tissue dehiscence (PSTD) coverage | 6 and 12 months | Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage) |
| Mucosal thickness changes | 3, 6 and 12 months | Changes within the mucosal thickness measured with ultrasonography (expressed in mm) |
| Complete peri-implant soft tissue dehiscence (PSTD) coverage | 6 and 12 months | Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage) |
| Post-operative pain | 14 days after the surgery | Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale \[VAS\]) |
| Professional esthetic assessment | 12 months | Esthetic outcomes of the treatment assessed by a calibrated operator using the Implant soft tissue Dehiscence coverage Esthetic Score (IDES) (expressed using points, based on the IDES classification system from Zucchelli et al. 2021) |
| 3D Volumetric changes | 3, 6 and 12 months | Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm\^3) |
Countries
United States
Outcome results
None listed