NCT06433986

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 23, 2024

Last Update Submit

May 23, 2024

Conditions

Gingival Recession

Keywords

gingival recessionestheticsphenotype

Outcome Measures

Primary Outcomes (1)

  • Root coverage percentage

    percentage of root coverage will be calculated by using pre and post operative recession depth

    6 months

Study Arms (2)

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.

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.

Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

Interventions

Modified Coronally Advanced Tunnel (MCAT)TechniquePROCEDURE

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.

Modified Coronally Advanced Tunnel (MCAT)Technique
Vestibular Incision Subperiosteal Tunnel Access (VISTA)TechniquePROCEDURE

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.

Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • ROHAN GOYAL, BDS

    PGIDS, Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SHIKHA TEWARI, MDS

CONTACT

9416514600drshikhatewari@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

June 1, 2024

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)