Vertical Soft Tissue Augmentation With CTG vs ADM

Harvard Medical School (HMS and HSDM)28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Implant Complication

Interventions

Vertical soft tissue augmentationPROCEDURE

Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)

Vertical soft tissue augmentationPROCEDURE

Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

Complete peri-implant soft tissue dehiscence (PSTD) coverage

Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)

Time frame: 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)

Time frame: 12 months

Mucosal thickness changes

Changes within the mucosal thickness measured with ultrasonography (expressed in mm)

Time frame: 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)

Time frame: 3, 6, and 12 months

Post-operative pain

Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale \[VAS\])

Time frame: 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)

Central Contacts

Lorenzo Tavelli, DDS, MS

CONTACT

734-604-4364 lorenzo_tavelli@hsdm.harvard.edu

Data from ClinicalTrials.gov

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