Dental ImplantsNCT05466006
Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences
A study testing Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM) 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?
- Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2022to 30 Jun 2024
- 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
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin
Turin
Giacomo Baima, DDS, 00393497254708, giacomo.baima@unito.it
About this study
Official title: 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.
- Conditions
- Dental Implants
- Being tested
- Soft tissue augmentation with subepithelial connective tissue graft (SCTG), Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation with subepithelial connective tissue graft (SCTG)Procedure or surgery
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.
Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Active comparator | Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate Receives: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG) |
| Volume Stable Collagen Matrix (VCMX) | Experimental | Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix Receives: Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Subjective pain experienced by the patient expressed in a VAS scale
Measured: 12 months
Bleeding on probing (0 no bleeding, 1 presence of bleeding)
Bleeding after probing within 15 seconds
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start5 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
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
- NCT05466006
- Sponsor's protocol ID
- GFGTurin2
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferrarotti F, Baima G, Mohammadi G, Carboncini C, Romano F, Aimetti M. Peri-Implant Soft Tissue Increase at Small Buccal Bone Dehiscences With Either Volume-Stable Collagen Matrix or Connective Tissue Graft: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Jul;36(7):846-858. doi: 10.1111/clr.14430. Epub 2025 Mar 19.
PubMed 40105088
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. 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 Volume-stable Collagen Matrix or Connective Tissue Graft: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05466006
- Acronym / sponsor ID
- GFGTurin2
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Jul 2022 (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 volume stable collagen matrix 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
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subepithelial Connective Tissue Graft (SCTG) | Active comparator | Procedure: Soft tissue augmentation with 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 |
| Volume Stable Collagen Matrix (VCMX) | Experimental | Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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. | Procedure or surgery | Subepithelial Connective Tissue Graft (SCTG) |
| 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. | Procedure or surgery | Volume Stable Collagen Matrix (VCMX) |
Primary outcome
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
Time frame: 12 months
Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin
Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)
Time frame: 12 months
The distance between the buccal soft tissue margin and the base of the pocket
Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)
Time frame: 12 months
The distance between the crown margin and the mucosal margin
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
Time frame: 12 months
Subjective pain experienced by the patient expressed in a VAS scale
Bleeding on probing (0 no bleeding, 1 presence of bleeding)
Time frame: 12 months
Bleeding after probing within 15 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 40105088Ferrarotti F, Baima G, Mohammadi G, Carboncini C, Romano F, Aimetti M. Peri-Implant Soft Tissue Increase at Small Buccal Bone Dehiscences With Either Volume-Stable Collagen Matrix or Connective Tissue Graft: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Jul;36(7):846-858. doi: 10.1111/clr.14430. Epub 2025 Mar 19.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue augmentation with subepithelial connective tissue graft (SCTG) and Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM) 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Aimetti (00390116331546, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466006, which also lists 1 linked publication.
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 28 Nov 2023.