Edentulous Alveolar Ridge AtrophyNCT05458271
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
A study testing VCMX and CTG in people with Edentulous Alveolar Ridge Atrophy and Soft Tissue Augmentation At Dental Implants, run by University of Florence at 1 site in Italy.
Trial summary
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation At Dental Implants
- What is being tested?
- VCMX and CTG
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2022to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- No systemic diseases or pregnancy.
- Self-reported smoking ≤10 cigarettes/day.
- No probing depths ≥5 mm
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
- Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering.
- Need of soft tissue augmentation for aesthetic purpose and/or functional reasons
- No previous soft tissue augmentation procedure at experimental site.
Who cannot join
- General contraindications for dental and/or surgical treatments
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
- Inflammatory and autoimmune disease of oral cavity
- History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
- Radiotherapy of head area
- Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
Show all 14Show fewer
- Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
- Untreated acute periodontal disease
- Patients who smoke more than 10 cigarettes/day will be excluded from the study
- Diabetes
- Allergy to the collagen
- Pregnant or lactating women
- Women of child bearing age, not using a highly effective method of birth control
- Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.
The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
- Being tested
- VCMX, CTG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCMXDevice
A flap will be raised and VCMX will be placed in order to increase the soft tissue volume
CTGProcedure or surgery
A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume
| Study group | Role | What they receive |
|---|---|---|
| VCMX | Experimental | All patients will be treated by scaling/root planing to obtain infection control if needed. In addition, patients will receive oral hygiene instructions.
The test group will be treated with add of VCMX. Following the local anesthesia, a split thickness flap will be raised-up to uncover the implant screw. Care will be taken to preserve pre-existing KT amount. A mesio-distal and apical partial thickness dissection will be performed to release residual muscle tension and allow the passive apical displacement of the flap. The randomisation envelope will be then opened. In test group the VCMX will be gently shaped and secured under the flap with suture. Care will be applied to completely cover the xenograft. Receives: Device: VCMX |
| CTG | Active comparator | The control group patients will be treated by flap surgery with add of CTG. In the control group (APF) a CTG harvested from palate will be secured under the flap with suture. Receives: Procedure: CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: Immediately After Surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 1 week After surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 2 weeks After surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 4 weeks After surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 3 months After surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 6 months after surgery
GT
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 12 months after surgery
Secondary outcomes (14)
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100))
Measured: Immediately After Surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 1 week After surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 2 weeks After surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 4 weeks After surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 3 months After surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 6 months after surgery
PROMs
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)
Measured: 12 months after surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: At Baseline
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 1 week After surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 2 weeks After surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 4 weeks After surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 3 months After surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 6 months after surgery
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start31 Jul 2022
- Primary completion31 Oct 2023
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge AtrophyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francesco Cairo, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458271
- Sponsor's protocol ID
- VCMX vs CTG
- Status last verified
- Dec 2024
- First submitted
- 5 Jul 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05458271
- Acronym / sponsor ID
- VCMX vs CTG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 14 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.
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.
The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCMX | Experimental | Device: VCMXAll patients will be treated by scaling/root planing to obtain infection control if needed. In addition, patients will receive oral hygiene instructions. The test group will be treated with add of VCMX. Following the local anesthesia, a split thickness flap will be raised-up to uncover the implant screw. Care will be taken to preserve pre-existing KT amount. A mesio-distal and apical partial thickness dissection will be performed to release residual muscle tension and allow the passive apical displacement of the flap. The randomisation envelope will be then opened. In test group the VCMX will be gently shaped and secured under the flap with suture. Care will be applied to completely cover the xenograft. |
| CTG | Active comparator | Procedure: CTGThe control group patients will be treated by flap surgery with add of CTG. In the control group (APF) a CTG harvested from palate will be secured under the flap with suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- No systemic diseases or pregnancy.
- Self-reported smoking ≤10 cigarettes/day.
- No probing depths ≥5 mm
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
Key exclusion criteria (14 listed)
- General contraindications for dental and/or surgical treatments
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
- Inflammatory and autoimmune disease of oral cavity
- History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
- Radiotherapy of head area
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 |
|---|---|---|
| VCMXA flap will be raised and VCMX will be placed in order to increase the soft tissue volume | Device | VCMX |
| CTGA flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume | Procedure or surgery | CTG |
Primary outcome
GT
Time frame: Immediately After Surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 1 week After surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 2 weeks After surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 4 weeks After surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 3 months After surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 6 months after surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
GT
Time frame: 12 months after surgery
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
14 secondary outcomes
PROMs
Time frame: Immediately After Surgery
PROMs
Time frame: 1 week After surgery
PROMs
Time frame: 2 weeks After surgery
PROMs
Time frame: 4 weeks After surgery
PROMs
Time frame: 3 months After surgery
PROMs
Time frame: 6 months after surgery
PROMs
Time frame: 12 months after surgery
KT
Time frame: At Baseline
KT
Time frame: 1 week After surgery
KT
Time frame: 2 weeks After surgery
KT
Time frame: 4 weeks After surgery
KT
Time frame: 3 months After surgery
KT
Time frame: 6 months after surgery
KT
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 VCMX and CTG in people with Edentulous Alveolar Ridge Atrophy and Soft Tissue Augmentation At Dental Implants, run by University of Florence 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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
GT (time frame: Immediately After Surgery). The study lists 7 primary outcomes in all. 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 6 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.