Vertical Soft Tissue Augmentation With CTG vs ADM

Implant Complication Clinical Trial

Official title:

Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729607
• Other study ID #: ITI IMP (22-0600)
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: November 27, 2025

Study information

• Verified date: June 2023
• 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 vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: November 27, 2025
• Est. primary completion date: February 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

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)
• 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

Related Conditions & MeSH terms

• Implant Complication

Intervention

Procedure:
• Vertical soft tissue augmentation
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
• Vertical soft tissue augmentation
Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

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	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
Secondary	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
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)	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 (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