Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

Implant Complication Clinical Trial

Official title:

Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576922
• Other study ID #: Delta IMPL REC (IRB22-0637)
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: October 21, 2025

Study information

• Verified date: January 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: Lorenzo Tavelli, DDS, MS
• Phone: 734-604-4364
• Email: lorenzo_tavelli[@]hsdm.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 21, 2025
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Implant Complication

Intervention

Other:
• Prosthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
• Prosthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue dehiscence reduction	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)	6 and 12 months
Secondary	Complete peri-implant soft tissue dehiscence (PSTD) coverage	Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)	6 and 12 months
Secondary	mean peri-implant soft tissue dehiscence (PSTD) coverage	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)	6 and 12 months
Secondary	Mucosal thickness changes	Changes within the mucosal thickness measured with ultrasonography (expressed in mm)	3, 6 and 12 months
Secondary	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
Secondary	Post-operative pain	Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS])	14 days after the surgery
Secondary	Professional esthetic assessment	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)	12 months