Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Volume-stable Collagen Matrix or Connective Tissue Graft: a Randomized Controlled Clinical Trial

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG); Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)

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

Contacts and Locations

• Study Contact: Name: Mario Aimetti; Phone Number: 00390116331546; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy
    • Recruiting
    • University of Turin
    • Contact: Giacomo Baima, DDS; Phone Number: 00393497254708; Email: giacomo.baima@unito.it

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Single tooth edentulous space
• Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT
• Completed non-surgical periodontal therapy (if needed)
• FMPS and FMBS < 20%

Exclusion Criteria:

• Age < 18 years old
• Pregnancy or lactation
• Heavy smokers (> 10 cigarette/day)
• Conditions or diseases contraindicating surgical interventions
• Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement
• Need for bone regeneration at the implant site

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subepithelial Connective Tissue Graft (SCTG); Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate	Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG); After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), SCTG will be harvested from the palate and sutured to the flap. Simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.
Experimental: Volume Stable Collagen Matrix (VCMX); Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix	Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM); After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), VCMX will be sutured to the flap and simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)	Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin	12 months
Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)	The distance between the buccal soft tissue margin and the base of the pocket	12 months
Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)	The distance between the crown margin and the mucosal margin	12 months
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	Subjective pain experienced by the patient expressed in a VAS scale	12 months
Bleeding on probing (0 no bleeding, 1 presence of bleeding)	Bleeding after probing within 15 seconds	12 months

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 16, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GFGTurin2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No