Gingival Recession, GeneralizedNCT05693753
Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions
A study testing Use of XCM for the treatment of MAGRs with mCAF technique and Treatment of MAGRs with CTG in people with Gingival Recession, Generalized, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Generalized
- What is being tested?
- Use of XCM for the treatment of MAGRs with mCAF technique and Treatment of MAGRs with CTG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to 2 Dec 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
- At least 18 years old and able to sign informed consent
- At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
- A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
- Available to attend study related procedures (including follow-up visits)
Who cannot join
- Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
- Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
- Pregnant or nursing women;
- History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
- Furcation involvement in the teeth to be included;
- Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
- Presence of fixed or removable prosthesis in the area to be treated
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CIR Dental School
Turin, 10126
Mario Aimetti, Prof., +39116331541, mario.aimetti@unito.it
About this study
Official title: Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.
- Conditions
- Gingival Recession, Generalized
- Being tested
- Use of XCM for the treatment of MAGRs with mCAF technique, Treatment of MAGRs with CTG
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of XCM for the treatment of MAGRs with mCAF techniqueDevice
After local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
Treatment of MAGRs with CTGProcedure or surgery
After local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
| Study group | Role | What they receive |
|---|---|---|
| Xenogenic collagen matrix (XCM) | Experimental | Multiple coronally advanced flap technique (mCAF) with the use of a XCM Receives: Device: Use of XCM for the treatment of MAGRs with mCAF technique |
| Connective tissue graft (CTG) | Active comparator | Multiple coronally advanced flap technique (mCAF) with the use of a CTG Receives: Procedure: Treatment of MAGRs with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Recession Reduction (RecRed)
Mean changes in mm in recession depth between baseline and 1-year
Measured: 6 months; 1 year
Secondary outcomes (4)
Complete Root Coverage (CRC)
Percentage of sites with complete root coverage after 1-year
Measured: 6 months; 1 year
Mean Root Coverage (MRC)
Percentage of mean root coverage after 1-year
Measured: 6 months; 1 year
Keratinised tissue height (KTH) changes
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Measured: 6 months; 1 year
Post-operative morbidity (pain, swelling, discomfort)
Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start2 Feb 2023
- Primary completion2 Jun 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, GeneralizedStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693753
- Sponsor's protocol ID
- XCMTurin
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05693753
- Acronym / sponsor ID
- XCMTurin
- Conditions
- Gingival Recession, Generalized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Jun 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 23 Jan 2023 (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.
The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenogenic collagen matrix (XCM) | Experimental | Device: Use of XCM for the treatment of MAGRs with mCAF techniqueMultiple coronally advanced flap technique (mCAF) with the use of a XCM |
| Connective tissue graft (CTG) | Active comparator | Procedure: Treatment of MAGRs with CTGMultiple coronally advanced flap technique (mCAF) with the use of a CTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old and able to sign informed consent
- At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
- A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
- Available to attend study related procedures (including follow-up visits)
Key exclusion criteria (7 listed)
- Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
- Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
- Pregnant or nursing women;
- History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
- Furcation involvement in the teeth to be included;
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 |
|---|---|---|
| Use of XCM for the treatment of MAGRs with mCAF techniqueAfter local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction. | Device | Xenogenic collagen matrix (XCM) |
| Treatment of MAGRs with CTGAfter local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction. | Procedure or surgery | Connective tissue graft (CTG) |
Primary outcome
Mean Recession Reduction (RecRed)
Time frame: 6 months; 1 year
Mean changes in mm in recession depth between baseline and 1-year
4 secondary outcomes
Complete Root Coverage (CRC)
Time frame: 6 months; 1 year
Mean Root Coverage (MRC)
Time frame: 6 months; 1 year
Keratinised tissue height (KTH) changes
Time frame: 6 months; 1 year
Post-operative morbidity (pain, swelling, discomfort)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recession, Generalized
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
RecruitingPhase 2/3
Surgical Treatment for Gingival Recessions After Orthodontic Treatment
Gingival Recessions, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized
Recruiting
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Maxilla.
Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate
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 Use of XCM for the treatment of MAGRs with mCAF technique and Treatment of MAGRs with CTG in people with Gingival Recession, Generalized, 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 7 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 Jun 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, MD (0116331546, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Recession Reduction (RecRed) (time frame: 6 months; 1 year). 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 28 Jun 2023.