## Protocol Section
### Identification Module
**NCT ID:** NCT06433973

**Brief Title:** Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects

**Official Title:** Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT

#### Organization Study ID Info
**ID:** Anisha Kumari Perio 24/36
#### 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:** Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root.

Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs).

Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement.

It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.

**Detailed Description:** Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results.

Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization.

.LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group

### Conditions Module

**Conditions:**

- Gingival Recession

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 51

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser.

**Intervention Names:**

- Procedure: Test group 1 - CM+LLLT+VISTA

**Label:** Test group 1 - CM+LLLT+VISTA

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique.

**Intervention Names:**

- Procedure: Test group 2 - CM+VISTA

**Label:** Test group 2 - CM+VISTA

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

**Intervention Names:**

- Procedure: Control group - SCTG+VISTA

**Label:** Control group - SCTG+VISTA

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test group 1 - CM+LLLT+VISTA

**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec.

**Name:** Test group 1 - CM+LLLT+VISTA

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Test group 2 - CM+VISTA

**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures.

**Name:** Test group 2 - CM+VISTA

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Control group - SCTG+VISTA

**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

**Name:** Control group - SCTG+VISTA

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** ( Preoperative recession depth) - (Postoperative recession depth) × 100

Preoperative recession depth

**Measure:** Percentage root coverage

**Time Frame:** 6 months

**Description:** recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.

**Measure:** Keratinised tissue width

**Time Frame:** 6 months

**Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region

**Measure:** interproximal Clinical attachment level (iCAL)

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** will be recorded as 1(present) if bleeding occurs within 15 seconds of probing and 0(absent) if no bleeding occurs. It will be calculated in percentage %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by hundred. It will be designed as percentage sites with bleeding on probing

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

**Time Frame:** 6 months

**Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the mid-buccal region

**Measure:** Buccal Clinical attachment level

**Time Frame:** 6 months

**Description:** The GT will be assessed by probe transparency (TRAN) method

. Gingival thickness will be measured from the keratinized mucosa to the periosteum with a finger spreader and a silicon slider and digital calliper at a point lying in the centre of a line drawn from the gingival margin to mucogingival junction

**Measure:** change in Gingival thickness

**Time Frame:** 6 months

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

**Measure:** Recession depth

**Time Frame:** 6 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

**Time Frame:** 6 months

**Description:** Measured in mm from the crest of the gingival margin to the base of the pocket at the mid-labial region

**Measure:** Pocket probing depth

**Time Frame:** 6 months

**Description:** The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. Postoperative pain using visual analog scale at treated site (VAS: a scale from 0-10 ; 0 means no pain/discomfort, 10 means maximum pain /discomfort )

**Measure:** Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
* Systemically healthy individuals.
* Absence of clinical tooth mobility.
* Age \>18 years old.
* A full mouth plaque index \< 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.
* patient with active periodontal disease
* smokers and tobacco users
* mal-alingned lower anteriors.
* patients who had already undergone root coverage procedure on the selected site.
* pregnant and lactating females
* Involved tooth with trauma from occlusion.
* Involved tooth with prosthesis.
* Endodontically involved/ RCT treated tooth
* Tooth with cervical abrasion / undetectable CEJ/ carious.

**Healthy Volunteers:** True

**Maximum Age:** 50 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:** 8708249475

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Country:** India

**Facility:** PGIDS

**State:** Haryana

**Zip:** 124001

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS, Rohtak

**Name:** Anisha Kumari, 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: 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
