Vertical Soft Tissue Augmentation With CTG vs ADM

• Sponsor: Harvard Medical School (HMS and HSDM) (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05729607
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Implant Complication	Procedure: Vertical soft tissue augmentation; Procedure: Vertical soft tissue augmentation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel-armParallel-arm
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 27, 2025
• Anticipated Study Completion Date: Nov 27, 2025

Arms and Interventions

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)
Experimental: Dermal matrix + EMD Acellular dermal matrix and enamel matrix derivative	Procedure: Vertical soft tissue augmentation; Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

Outcome Measures

Primary Outcome Measures

1. Change in Soft tissue dehiscence depth [12 months]

   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)

Secondary Outcome Measures

1. Complete peri-implant soft tissue dehiscence (PSTD) coverage [12 months]

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

2. mean peri-implant soft tissue dehiscence (PSTD) coverage [12 months]

   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)

3. Mucosal thickness changes [3, 6, and 12 months]

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

4. 3D Volumetric changes [3, 6, and 12 months]

   Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3)

5. Post-operative pain [14 days after the surgery]

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

6. Professional esthetic assessment (IDES) [12 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard School of Dental Medicine	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Harvard Medical School (HMS and HSDM)

Investigators

• Principal Investigator: Lorenzo Tavelli, DDS, MS, Harvard School of Dental Medicine, Boston, USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lorenzo Tavelli, Assistant Professor, Harvard Medical School (HMS and HSDM)
• ClinicalTrials.gov Identifier: NCT05729607
• Other Study ID Numbers: ITI IMP (22-0600)
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Feb 16, 2023