MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession

May 23, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIDS
        • Contact:
        • Principal Investigator:
          • ROHAN GOYAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA-

  • 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.

EXCLUSION CRITERIA-

  • 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.
  • Involved tooth with trauma from occlusion
  • Involved tooth with prosthesis.
  • Endodontically treated tooth.
  • Tooth with cervical abrasion/undetectable CEJ/ caries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Coronally Advanced Tunnel (MCAT)Technique
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.
Procedure: Modified Coronally Advanced Tunnel (MCAT)Technique
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.
Active Comparator: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
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.
Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root coverage percentage
Time Frame: 6 months
percentage of root coverage will be calculated by using pre and post operative recession depth
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: ROHAN GOYAL, BDS, PGIDS, ROHTAK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rohan Goyal Perio 24/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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