## Protocol Section
### Identification Module
**NCT ID:** NCT06433986

**Brief Title:** MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession

**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

#### Organization Study ID Info
**ID:** Rohan Goyal Perio 24/35
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Postgraduate Institute of Dental Sciences Rohtak

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Gingival Recession

**Keywords:**

- gingival recession

- esthetics

- phenotype

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Modified Coronally Advanced Tunnel (MCAT)Technique

**Label:** Modified Coronally Advanced Tunnel (MCAT)Technique

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

**Label:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Modified Coronally Advanced Tunnel (MCAT)Technique

**Description:** 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.

**Name:** Modified Coronally Advanced Tunnel (MCAT)Technique

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

**Description:** 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.

**Name:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Root coverage percentage

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drshikhatewari@yahoo.com

**Name:** SHIKHA TEWARI, MDS

**Phone:** 9416514600

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Contacts:**

***Contact 1:***

- **Email:** drshikhatewari@yahoo.com

- **Name:** Dr. Shikha Tewari, MDS

- **Phone:** 09416514600

- **Role:** CONTACT

***Contact 2:***

- **Name:** ROHAN GOYAL

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** India

**Facility:** PGIDS

**State:** Haryana

**Zip:** 124001

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS, Rohtak

**Name:** ROHAN GOYAL, BDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005882

- Term: Gingival Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000055093

- Term: Periodontal Atrophy

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9001

- Name: Gingival Recession

- Relevance: HIGH

- As Found: Gingival Recession

- ID: M1112

- Name: Surgical Wound

- Relevance: LOW

- As Found: Unknown

- ID: M8994

- Name: Gingival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M28025

- Name: Periodontal Atrophy

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005889

- Term: Gingival Recession

### Misc Info Module

- Version Holder: 2024-05-31
