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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective tissue graft | Active Comparator | Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized |
|
| Dermal matrix + EMD | Experimental | Acellular dermal matrix and enamel matrix derivative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertical soft tissue augmentation | Procedure | Vertical soft tissue augmentation with autogenous connective tissue graft (CTG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Soft tissue dehiscence depth | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete peri-implant soft tissue dehiscence (PSTD) coverage | Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage) | 12 months |
| mean peri-implant soft tissue dehiscence (PSTD) coverage |
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Inclusion criteria:
Exclusion criteria are:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Tavelli, DDS, MS | Contact | 734-604-4364 | lorenzo_tavelli@hsdm.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Tavelli, DDS, MS | Harvard School of Dental Medicine, Boston, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard School of Dental Medicine | Recruiting | Boston | Massachusetts | 02115 | United States |
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Parallel-arm
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| Vertical soft tissue augmentation | Procedure | Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD) |
|
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)
| 12 months |
| Mucosal thickness changes | Changes within the mucosal thickness measured with ultrasonography (expressed in mm) | 3, 6, and 12 months |
| 3D Volumetric changes | Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3) | 3, 6, and 12 months |
| Post-operative pain | Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS]) | 14 days after the surgery |
| Professional esthetic assessment (IDES) | 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) | 12 months |