Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Connective tissue graft Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized |
Other: Prosthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
|
| Experimental: Collagen matrix + rhPDGF-BB Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB |
Other: Prosthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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)
- 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)
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years,
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Periodontally and systemically healthy,
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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,
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Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
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Ability to perform good oral hygiene
Exclusion Criteria:
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Contraindications for surgery,
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Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
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Patients pregnant or attempting to get pregnant (self-reported),
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Untreated periodontitis,
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Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018),
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Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harvard School of Dental Medicine | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Harvard Medical School (HMS and HSDM)
Investigators
- Principal Investigator: Lorenzo Tavelli, DDS, MS, Harvard School of Dental Medicine, Boston, USA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Delta IMPL REC (IRB22-0637)