Vertical Soft Tissue Augmentation With CTG vs ADM

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

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

Study Overview

• Status: Recruiting
• Conditions: Implant Complication
• Intervention / Treatment: Procedure: Vertical soft tissue augmentation; Procedure: Vertical soft tissue augmentation

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorenzo Tavelli, DDS, MS; Phone Number: 734-604-4364; Email: lorenzo_tavelli@hsdm.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Harvard School of Dental Medicine
      • Contact: Lorenzo Tavelli, DDS, MS; Phone Number: 7346044364; Email: lorenzo_tavelli@hsdm.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	Procedure: Vertical soft tissue augmentation; Vertical soft tissue augmentation with autogenous connective tissue graft (CTG); Procedure: Vertical soft tissue augmentation; Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)
Experimental: Dermal matrix + EMD; Acellular dermal matrix and enamel matrix derivative	Procedure: Vertical soft tissue augmentation; Vertical soft tissue augmentation with autogenous connective tissue graft (CTG); Procedure: Vertical soft tissue augmentation; Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS])	14 days after the surgery
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	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
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

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Lorenzo Tavelli, DDS, MS, Harvard School of Dental Medicine, Boston, USA

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): November 27, 2027

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ITI IMP (22-0600)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No