Implant Complication
Conditions
Brief summary
The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative
Detailed description
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic, and patient-reported outcomes will be evaluated at different time points up to 1 year.
Interventions
PROCEDUREVertical soft tissue augmentation
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
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 99 Years
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) * Presence of single functional dental implant in the anterior with a PSTD * Implants diagnosed as healthy (Berglundh et al., 2018)
Exclusion criteria
are: * 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 within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Soft tissue dehiscence depth | 12 months | Change 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) at 12 months compared to baseline (expressed in millimeters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean peri-implant soft tissue dehiscence (PSTD) coverage | 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 | 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 (IDES) | 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) The range is from 0 (worst outcome) to 10 (best outcome) |
| 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
Contacts
Primary ContactLorenzo Tavelli, DDS, MS
Outcome results
None listed