## Protocol Section
### Identification Module
**NCT ID:** NCT06432439

**Brief Title:** Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.

**Official Title:** Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial

#### Organization Study ID Info
**ID:** Amisha perio
#### 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:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### 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:** False

### Description Module

**Brief Summary:** Gingival Recession (GR) is a common finding in among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.

A flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.

The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.

**Detailed Description:** Gingival recession is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.

### Conditions Module

**Conditions:**

- Gingival Recession, Localized

**Keywords:**

- microneedling

- phenotype

- gingival recession

- coronally advanced flap

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures

**Intervention Names:**

- Procedure: microneedling followed by CAF procedures

**Label:** TEST GROUP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.

**Intervention Names:**

- Procedure: CAF procedure

**Label:** CONTROL GROUP

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TEST GROUP

**Description:** microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage

**Name:** microneedling followed by CAF procedures

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- CONTROL GROUP

**Description:** RT1 gingival recession coverage by CAF procedures alone.

**Name:** CAF procedure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

**Measure:** Recession Depth

**Time Frame:** 3 months

**Description:** recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

**Measure:** RECESSION WIDTH (RW)

**Time Frame:** 3 months

**Description:** calculated according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative

**Measure:** ROOT COVERAGE PERCENTAGE

**Time Frame:** 3 months

**Description:** GT is measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper

**Measure:** Gingival thickness(GT)

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Clinical attachment level will be measured as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth

**Measure:** CLINICAL ATTACHMENT LEVEL (CAL)

**Time Frame:** 3 months

**Description:** Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe

**Measure:** Probing Pocket Depth (PPD)

**Time Frame:** 3 months

**Description:** It will be measured by walking the periodontal probe at 6 sites of each tooth

**Measure:** Bleeding on Probing (BOP)

**Time Frame:** 3 months

**Description:** For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva

**Measure:** Plaque Index (PI)

**Time Frame:** 3 months

**Description:** Gingival index by Loe and Silness (1963)22 will be used to assess severity of gingival inflammation

**Measure:** Gingival Index (GI

**Time Frame:** 3 months

**Description:** Keratinized tissue width will be measured with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper

**Measure:** Keratinized Tissue Width (KTW)

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** INCLUSION CRITERIA:

* Presence of isolated (RT1) by Cairo et al 2011 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
* Gingival Recession ≥2mm and clinically identifiable CEJ
* Age 20years-50 years
* Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 thearpy Plaque index (PI) \<1, Gingival Index (GI) \<1
* Providing a written and verbal informed consent.

EXCLUSION CRITERIA

* Patient with systemic disease that can influence the outcome of therapy.
* Pregnant females or on oral contraceptive pills or hormone replacement therapy.
* Smokers and patients undergoing orthodontic therapy
* Physically and mentally impaired patients.
* Non vital, malpositioned tooth
* Presence of cervical abrasions or restorations in the area
* Previous history of periodontal surgery on the involved sites.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nsh_tanwar@yahoo.co.in

**Name:** Nishi Tanwar, MDS

**Phone:** 8368126310

**Role:** CONTACT

**Contact 2:**

**Email:** amishagoyal97@gmail.com

**Name:** Amisha Goyal, BDS

**Phone:** 9718413637

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS

**Name:** Amisha Goyal, BDS

**Role:** PRINCIPAL_INVESTIGATOR

## 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: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9001

- Name: Gingival Recession

- Relevance: HIGH

- As Found: Gingival Recession

- 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
