Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Connective Tissue Graft or Guided Bone Regeneration: a Randomized Controlled 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 guided bone regeneration and evaluated at 3 months after surgery and at 12 months of follow up after crown placement

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Connective tissue graft; Procedure: horizontal guided bone regeneration

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Torino, Torino, Italy, 10126
      • C.I.R. Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ≥18 years of age
• Patients requiring a single dental implant in a healed site in the posterior region (premolar or molar areas)
• Presence of a buccal bone dehiscence defect at implant placement, defined as a vertical defect of the buccal bone plate ≥1 mm and ≤3 mm measured from the implant shoulder after implant insertion
• Adequate residual bone to allow implant placement with primary stability (insertion torque ≥25 Ncm or ISQ ≥60)
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
• Patients able to understand and sign informed consent
• Patients willing to comply with study procedures and follow-up visits

Exclusion Criteria:

• Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, HbA1c >7.5%)
• Immunocompromised patients
• History of radiotherapy in the head and neck region
• Use of medications affecting bone metabolism (e.g., bisphosphonates, denosumab)
• Pregnancy or lactation

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
Experimental: Connective tissue graft; Autogenous connective tissue graft harvested from the palate and placed at the buccal aspect of the implant at the time of implant placement.	Procedure: Connective tissue graft; Following implant placement, a connective tissue graft (CTG) will be harvested from the patient's palate using a standardized technique. The graft will be trimmed and adapted to the buccal aspect of the implant site and stabilized with sutures to increase peri-implant soft tissue thickness. Flap management will be performed to ensure passive adaptation and primary closure. Healing abutments will be placed.
Active Comparator: Horizontal guided bone regeneration; Guided bone regeneration using xenogeneic bone substitute and resorbable collagen membrane at the buccal aspect of the implant.	Procedure: horizontal guided bone regeneration; Following implant placement, guided bone regeneration (GBR) will be performed at the buccal aspect of the implant using a xenogeneic bone substitute to fill the dehiscence defect. The graft material will be covered with a resorbable collagen membrane, which will be stabilized to ensure defect containment. Flap advancement will be performed to obtain tension-free primary closure. Healing abutments will be placed according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal soft tissue contour change (profilometric analysis)	Change in buccal soft tissue contour assessed by profilometric analysis through superimposition of digital surface scans (intraoral scans). Linear and/or volumetric changes at the buccal aspect of the implant site will be quantified using dedicated software.	12 months after prosthetic loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Level (MBL) change	Change in marginal bone levels measured on standardized periapical radiographs using customized holders. Measurements will be taken from the implant shoulder to the first bone-to-implant contact.	12 months after prosthetic loading
Mucosal thickness gain	Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software.	12 months after prosthetic loading
Width of keratinized mucosa	Width of keratinized mucosa measured from the mucogingival junction to the free gingival margin at the mid-buccal aspect.	12 months after prosthetic loading
Pink Esthetic Score	Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners.	12 months after prosthetic loading

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GFGTurin3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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