Gingival Recession, GeneralizedNCT05370456
Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap
A study testing Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM and Treatment of MAGRs with mCAF technique and XCM 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 effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage… 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?
- Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM and Treatment of MAGRs with mCAF technique and XCM
- 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
- 3 May 2022to 10 Sep 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.
About this study
Official title: The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial
The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone 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) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.
- Conditions
- Gingival Recession, Generalized
- Being tested
- Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM, Treatment of MAGRs with mCAF technique and XCM
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCMDevice
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.
Treatment of MAGRs with mCAF technique and XCMProcedure or surgery
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM 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) + Hyaluronic acid (HA) | Experimental | Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel Receives: Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM |
| Xenogenic collagen matrix (XCM) | Active comparator | Multiple coronally advanced flap technique (mCAF) with the use of a XCM Receives: Procedure: Treatment of MAGRs with mCAF technique and XCM |
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 posted11 May 2022
- Study start3 May 2022
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 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
- Triple blind
- Who is masked
- Participant, 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
- NCT05370456
- Sponsor's protocol ID
- XCM+HA_Turin
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 19 May 2022
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05370456
- Acronym / sponsor ID
- XCM+HA_Turin
- 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
- 3 May 2022 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 11 May 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.
The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone 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) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA) | Experimental | Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCMMultiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel |
| Xenogenic collagen matrix (XCM) | Active comparator | Procedure: Treatment of MAGRs with mCAF technique and XCMMultiple coronally advanced flap technique (mCAF) with the use of a XCM |
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 |
|---|---|---|
| Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCMAfter local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied. | Device | Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA) |
| Treatment of MAGRs with mCAF technique and XCMAfter local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction. | Procedure or surgery | Xenogenic collagen matrix (XCM) |
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 19 May 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM and Treatment of MAGRs with mCAF technique and XCM 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 19 May 2022. 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, PA (00390116331541, 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 19 May 2022.