Comparison of Root Coverage Outcomes by NORD Flap Versus Subepithelial Connective Tissue Graft in RT1 Gingival Recession

NCT05844254 | Active Not Recruiting DMC

• 1 other identifier: Dr. Ritika Arora perio 2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Management of GR in the initial stages (when there is no inter proximal attachment and bone loss involved) has better clinical outcomes and reduces the chances of further progression of recession. Surgical treatment of recession involves techniques like pedicle grafts and free soft tissue grafts and their modifications. Sub epithelial connective tissue graft is considered as the gold standard in root coverage techniques. However this procedure involves a second surgical site increasing surgical time, complexity and patient morbidity. So there is a need of a technique which overcomes these limitations, is easier to perform and helps to achieve comparable root coverage with stable results over a long term. Novel overlapping rotated double (NORD) flap is a novel technique which offers a solution to this problem. This may help to achieve greater thickness of gingiva in the region of GR after healing and may reduce the risk of future recession. This technique is being compared with the bilaminar technique utilizing the sub epithelial connective tissue graft at the control sites, both the test and control groups will be treated using a microsurgical approach. If there is no significant difference in the root coverage achieved between the two techniques, this may reduce the need of harvesting connective tissue graft from a second surgical site. This technique is also expected to have better patient reported outcomes and will benefit the patients and operator both. This technique may also help to modify the phenotype of the affected tooth, thus making the results more stable.

Conditions

Gingival Recession

Keywords

Sub epithelial connective tissue graft; patient centered outcomes; phenotype

Outcome Measures

Primary Outcomes (16)

• Change in Recession depth

  change in recession depth from baseline at 1month will be assessed. The unit of measurement is millimeter.

  1month

• Change in Recession depth

  change in recession depth from baseline at 6months will be assessed. The unit of measurement is millimeter.

  6months

• Change in Recession depth

  change in recession depth from baseline at 12months will be assessed. The unit of measurement is millimeter.

  12months

• Change in Recession depth

  change in recession depth from baseline at 15months will be assessed. The unit of measurement is millimeter.

  15months

• Root coverage (%)- Change in recession depth/RD at baseline × 100

  change in recession depth from baseline to 1month will be assessed. The obtained value would be divided by recession depth at baseline. The value obtained would be multiplied by 100. The unit of measurement is millimeters.

  1month

• Root coverage (%)- change in recession depth/RD at baseline × 100

  change in recession depth from baseline to 6months will be assessed. The obtained value would be divided by recession depth at baseline. The value obtained would be multiplied by 100. The unit of measurement is millimeters.

  6 months

• Root coverage (%)-Change in recession depth/RD at baseline × 100

  change in recession depth from baseline to 12months will be assessed. The obtained value would be divided by recession depth at baseline. The value obtained would be multiplied by 100. The unit of measurement is millimeters.

  12months

• Root coverage (%)- change in recession depth/RD at baseline × 100

  change in recession depth from baseline to 15months will be assessed. The obtained value would be divided by recession depth at baseline. The value obtained would be multiplied by 100. The unit of measurement is millimeters.

  15months

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  24 hours after surgery

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  10 days after surgery

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  1month

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  6months

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  12 months

• Visual analog scale

  Patients will be asked to record their pain using Visual analog scale (VAS) from 0 to 100, with 0 representing no pain and 100 representing pain as bad as it could be.

  15 months

• Patient centered outcomes

  All Patient centered outcomes would be recorded in the questionnaire

  10 days after surgery

• Patient centered outcomes

  All Patient centered outcomes would be recorded in the questionnaire

  1month

Secondary Outcomes (38)

• Probing depth

  baseline

• Probing depth

  1month

• Probing depth

  6 months

• Probing depth

  12 months

• Probing depth

  15 months

Study Arms (2)

NORD group

EXPERIMENTAL

After undergoing phase one of periodontal therapy, patients will be recalled after four weeks for root coverage surgery. NORD group will undergo NORD flap for root coverage. Patients will be followed up after 1 month,6, 12 and 15 months. Patients belonging to thin phenotype will be followed up as separate cohort for period of one year to evaluate phenotype modification.

Procedure: novel overlapping rotated double (NORD) flap

Sub epithelial connective tissue group

ACTIVE COMPARATOR

After undergoing phase one of periodontal therapy, patients will be recalled after four weeks for root coverage surgery. Sub epithelial connective tissue group will receive sub epithelial connective tissue graft. Patients will be followed up after 1 month,6, 12 and 15 months. Patients belonging to thin phenotype will be followed up as separate cohort for period of one year to evaluate phenotype modification.

Procedure: novel overlapping rotated double (NORD) flap

Interventions

novel overlapping rotated double (NORD) flap PROCEDURE

After undergoing phase one of periodontal therapy, patients will be recalled after four weeks for root coverage surgery. Patients will be randomly allotted to either group by stratified block randomization after taking baseline measurement with respect to periodontal phenotype(PP) \[using transparency of periodontal probe through the gingival margin, when probe is visible, thin PP and when not visible, thick PP\] so that patients with thick and thin PP get an equal chance of being allocated to NORD and Sub epithelial connective tissue group. 1. Group 1(NORD group)- Patients treated with NORD flap 2. Group 2 (Sub epithelial connective tissue group)- Patients treated with sub epithelial connective tissue graft Patients will be followed up after 1 month,6, 12 and 15 months. 30 patients belonging to thin phenotype will be followed up as separate cohort for period of one year to evaluate phenotype modification.

NORD group; Sub epithelial connective tissue group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years
• Non smokers (current and past smokers
• Plaque index ≤1,Gingival index≤1
• RT1(Miller's class I and class II)gingival recession, that is, GR with no loss of inter proximal attachment
• Probing depth ≤3 mm
• Width of attached gingiva≥3 mm on the mesial and distal sides of the recipient tooth.
• Adequate vestibular depth

You may not qualify if:

• Patients with a history of any systemic condition that might alter the course of disease and
• or wound healing such as diabetes mellitus, immunologic disorders, cardio-vascular disease etc.
• Pregnant and lactating women.
• Patients with immature tooth.
• Patients with tooth fracture or tooth mobility
• Patients receiving treatment with antibiotics, statins, glucocorticoids, bisphosphonates or any other modulatory drug.
• Patients undergoing orthodontic treatment

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 110015, India

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Study Officials

• RITIKA ARORA, M.D.S.

  Post Graduate Institute of Dental Sciences, Rohtak

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: May 6, 2023
• Study Start: April 2, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)