Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

NCT07501715 | Completed

• 1 other identifier: GFGTurin3
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Marginal Bone Level (MBL) change

  12 months after prosthetic loading

• Mucosal thickness gain

  12 months after prosthetic loading

• Width of keratinized mucosa

  12 months after prosthetic loading

• Pink Esthetic Score

  12 months after prosthetic loading

Study Arms (2)

Connective tissue graft

EXPERIMENTAL

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

Horizontal guided bone regeneration

ACTIVE COMPARATOR

Guided bone regeneration using xenogeneic bone substitute and resorbable collagen membrane at the buccal aspect of the implant.

Procedure: horizontal guided bone regeneration

Interventions

horizontal guided bone regeneration PROCEDURE

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.

Horizontal guided bone regeneration

Connective tissue graft PROCEDURE

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.

Connective tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

C.I.R. Dental School

Torino, Torino, 10126, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: September 5, 2023
• Primary Completion: January 1, 2026
• Study Completion: March 24, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)