Dental ImplantsNCT07501715
Peri-implant Soft Tissue Changes at Small Buccal Dehiscences
A study testing Connective tissue graft and horizontal guided bone regeneration in people with Dental Implants, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Connective tissue graft and horizontal guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2023to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Dental Implants
- Being tested
- Connective tissue graft, horizontal guided bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
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.
horizontal guided bone regenerationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: horizontal guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after prosthetic loading
Secondary outcomes (4)
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.
Measured: 12 months after prosthetic loading
Mucosal thickness gain
Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software.
Measured: 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.
Measured: 12 months after prosthetic loading
Pink Esthetic Score
Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners.
Measured: 12 months after prosthetic loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start5 Sep 2023
- Primary completion1 Jan 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Aimetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501715
- Sponsor's protocol ID
- GFGTurin3
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Connective Tissue Graft or Guided Bone Regeneration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07501715
- Acronym / sponsor ID
- GFGTurin3
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft | Experimental | Procedure: Connective tissue graftAutogenous connective tissue graft harvested from the palate and placed at the buccal aspect of the implant at the time of implant placement. |
| Horizontal guided bone regeneration | Active comparator | Procedure: horizontal guided bone regenerationGuided bone regeneration using xenogeneic bone substitute and resorbable collagen membrane at the buccal aspect of the implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connective tissue graftFollowing 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. | Procedure or surgery | Connective tissue graft |
| horizontal guided bone regenerationFollowing 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. | Procedure or surgery | Horizontal guided bone regeneration |
Primary outcome
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.
4 secondary outcomes
Marginal Bone Level (MBL) change
Time frame: 12 months after prosthetic loading
Mucosal thickness gain
Time frame: 12 months after prosthetic loading
Width of keratinized mucosa
Time frame: 12 months after prosthetic loading
Pink Esthetic Score
Time frame: 12 months after prosthetic loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Implants
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft and horizontal guided bone regeneration in people with Dental Implants, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal soft tissue contour change (profilometric analysis) (time frame: 12 months after prosthetic loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.