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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729607
Other study ID # ITI IMP (22-0600)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 26, 2023
Est. completion date November 27, 2026

Study information

Verified date June 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
Health authority
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, 2026
Est. primary completion date February 27, 2026
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

Study Design


Related Conditions & MeSH terms


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
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