Gingival RecessionNCT06525285
MCAF and EMD With and Without CTG Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial
A study testing Connective tissue graft wall technique in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Connective tissue graft wall technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jul 2024to 30 Apr 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18-60 years
- Systemically healthy individuals
- Participants with Miller's Class III and IV or Cairo's RT3 gingival recession in maxillary and mandibular anteriors.
- Participants with Nordland and Tarnow's papillary recession of either I, II or III.
- Presence of interdental PPD, CAL and recession
- Radiographic evidence of interdental bone loss
- No prior experience of root coverage procedures
- Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS < 25% and FMBS < 25%).
Who cannot join
- Grade III mobile teeth
- Pathologically migrated teeth
- Endodontically treated teeth
- Open contacts
- Pregnancy and lactating women
- Participants with systemic conditions
Show all 10Show fewer
- Untreated periodontitis
- Persistence of uncorrected gingival trauma from tooth brushing
- Self-reported current smoking
- Presence of medical contraindications to elective surgery
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Prabhuji MLV
Bengaluru, Karnataka, 562157
Dr. Prabhuji MLV, MDS, 9448057407, prabhujimlv@gmail.com
Dr. Vinodini A, MDS, 9791810495, drvinosasi@gmail.com
About this study
Official title: Modified Coronally Advanced Flap and Enamel Matrix Derivative With and Without Connective Tissue Graft Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession.
Read the detailed description
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession. The objectives is to assess the probing pocket depth reduction, clinical attachment level gain, patient esthetic evaluation, complete root coverage and mean root coverage. the control group will be treated with modified coronally advanced flap with connective tissue graft and enamel matrix derivative and the study group will be treated with modified coronally advanced flap with connective tissue graft wall and enamel matrix derivative. The total number of participants included will be 24 (Control-12; Study-12) with a 6 month follow up.
- Conditions
- Gingival Recession
- Being tested
- Connective tissue graft wall technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft wall techniqueProcedure or surgery
Also called Connective tissue graft technique
Harvested connective tissue graft will be placed over the exposed root surface like a wall to cover the gingival recession
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Connective tissue graft wall technique Receives: Procedure: Connective tissue graft wall technique |
| Control group | Active comparator | Connective tissue graft Receives: Procedure: Connective tissue graft wall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage
Mean root coverage Cairo's RT3 gingival recession treated with MCAF + CTG wall + EMD technique is non-inferior to MCAF + CTG + EMD in terms of root coverage.
Measured: 6 months
Secondary outcomes (1)
Gingival health and evaluation
clinical attachment level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start19 Jul 2024 (estimated)
- Primary completion12 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525285
- Sponsor's protocol ID
- 02_D012_147464
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Coronally Advanced Flap and Enamel Matrix Derivative With and Without Connective Tissue Graft Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06525285
- Acronym / sponsor ID
- 02_D012_147464
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 19 Jul 2024 (estimated)
- Primary completion
- 12 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Jul 2024 (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.
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession.
Detailed description
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession. The objectives is to assess the probing pocket depth reduction, clinical attachment level gain, patient esthetic evaluation, complete root coverage and mean root coverage. the control group will be treated with modified coronally advanced flap with connective tissue graft and enamel matrix derivative and the study group will be treated with modified coronally advanced flap with connective tissue graft wall and enamel matrix derivative. The total number of participants included will be 24 (Control-12; Study-12) with a 6 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Connective tissue graft wall techniqueConnective tissue graft wall technique |
| Control group | Active comparator | Procedure: Connective tissue graft wall techniqueConnective tissue graft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants aged 18-60 years
- Systemically healthy individuals
- Participants with Miller's Class III and IV or Cairo's RT3 gingival recession in maxillary and mandibular anteriors.
- Participants with Nordland and Tarnow's papillary recession of either I, II or III.
- Presence of interdental PPD, CAL and recession
Key exclusion criteria (10 listed)
- Grade III mobile teeth
- Pathologically migrated teeth
- Endodontically treated teeth
- Open contacts
- Pregnancy and lactating women
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 graft wall techniqueAlso: Connective tissue graft techniqueHarvested connective tissue graft will be placed over the exposed root surface like a wall to cover the gingival recession | Procedure or surgery | Control group, Study group |
Primary outcome
Root coverage
Time frame: 6 months
Mean root coverage Cairo's RT3 gingival recession treated with MCAF + CTG wall + EMD technique is non-inferior to MCAF + CTG + EMD in terms of root coverage.
1 secondary outcome
Gingival health and evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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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 Connective tissue graft wall technique in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 10 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 29 Jul 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 India. 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 Prabhuji MLV, MDS (9448057407, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root coverage (time frame: 6 months). 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 29 Jul 2024.