Gingival RecessionNCT06433986
MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession
A study testing Modified Coronally Advanced Tunnel (MCAT)Technique and Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Modified Coronally Advanced Tunnel (MCAT)Technique and Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2024to 31 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth>=6mm
- Systemically healthy individuals.
- Age >18 years old.
- A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) < 20%
- Patient showing adequate compliance and willing to participate in the study.
Who cannot join
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- Previous surgical attempt to correct gingival recession.
- Crowding of affected teeth and tooth without adjacent contact teeth.
- Patients with active periodontal disease.
- Smokers and tobacco users.
- Pregnant and lactating women.
Show all 10Show fewer
- Involved tooth with trauma from occlusion
- Involved tooth with prosthesis.
- Endodontically treated tooth.
- Tooth with cervical abrasion/undetectable CEJ/ caries.
Trial locations and contacts
1 site in 1 country.
India1 site
PGIDS
Rohtak, Haryana, 124001
Dr. Shikha Tewari, MDS, 09416514600, drshikhatewari@yahoo.com
ROHAN GOYAL
About this study
Official title: Management of Isolated RT 3 Gingival Recession With Modified Coronally Advanced Tunnel Versus Vestibular Incision Subperiosteal Tunnel Access With Volume Stable Collagen Matrix: A RCT
This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth.
Read the detailed description
Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft.
Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region.
- Conditions
- Gingival Recession
- Being tested
- Modified Coronally Advanced Tunnel (MCAT)Technique, Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
- Keywords
- gingival recession, esthetics, phenotype
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Coronally Advanced Tunnel (MCAT)TechniqueProcedure or surgery
Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT.
Vestibular Incision Subperiosteal Tunnel Access (VISTA)TechniqueProcedure or surgery
Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA.
| Study group | Role | What they receive |
|---|---|---|
| Modified Coronally Advanced Tunnel (MCAT)Technique | Experimental | Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT. Receives: Procedure: Modified Coronally Advanced Tunnel (MCAT)Technique |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique | Active comparator | Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA. Receives: Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage percentage
percentage of root coverage will be calculated by using pre and post operative recession depth
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 posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 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.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROHAN GOYAL, BDS, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433986
- Sponsor's protocol ID
- Rohan Goyal Perio 24/35
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Isolated RT 3 Gingival Recession With Modified Coronally Advanced Tunnel Versus Vestibular Incision Subperiosteal Tunnel Access With Volume Stable Collagen Matrix: A RCT
- ClinicalTrials.gov ID
- NCT06433986
- Acronym / sponsor ID
- Rohan Goyal Perio 24/35
- Conditions
- Gingival Recession
- Keywords
- gingival recession, esthetics, phenotype
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 May 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.
This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth.
Detailed description
Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft.
Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Coronally Advanced Tunnel (MCAT)Technique | Experimental | Procedure: Modified Coronally Advanced Tunnel (MCAT)TechniqueScaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT. |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique | Active comparator | Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)TechniqueScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth>=6mm
- Systemically healthy individuals.
- Age >18 years old.
- A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) < 20%
- Patient showing adequate compliance and willing to participate in the study.
Key exclusion criteria (10 listed)
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- Previous surgical attempt to correct gingival recession.
- Crowding of affected teeth and tooth without adjacent contact teeth.
- Patients with active periodontal disease.
- Smokers and tobacco users.
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 |
|---|---|---|
| Modified Coronally Advanced Tunnel (MCAT)TechniqueScaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT. | Procedure or surgery | Modified Coronally Advanced Tunnel (MCAT)Technique |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA)TechniqueScaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA. | Procedure or surgery | Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique |
Primary outcome
Root coverage percentage
Time frame: 6 months
percentage of root coverage will be calculated by using pre and post operative recession depth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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.
ROHAN GOYAL, BDS principal investigator
PGIDS, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Coronally Advanced Tunnel (MCAT)Technique and Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak 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 5 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 30 May 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 SHIKHA TEWARI, MDS (9416514600, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root coverage percentage (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 30 May 2024.