Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

March 24, 2026 updated by: Mario Aimetti, University of Turin, Italy

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Buccal soft tissue contour change (profilometric analysis)
Time Frame: 12 months after prosthetic loading
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marginal Bone Level (MBL) change
Time Frame: 12 months after prosthetic loading
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
Time Frame: 12 months after prosthetic loading
Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software.
12 months after prosthetic loading
Width of keratinized mucosa
Time Frame: 12 months after prosthetic loading
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
Time Frame: 12 months after prosthetic loading
Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners.
12 months after prosthetic loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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