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

NCT ID: NCT05844254

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2025-12-31

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.

Detailed Description

Gingival recession (GR) is a very frequent finding in the general population with a prevalence ranging from 50-90% in different populations. Patients with GR may experience hypersensitivity, pain, poor esthetics and difficulty in maintaining oral hygiene. Among the predisposing factors for GR, most common are improper tooth brushing, gingival inflammation, thin periodontal phenotype, aberrant frenum, areas with inadequate keratinized gingiva, orthodontic movement leading to buccal tooth displacement and direct trauma. Literature suggests that untreated gingival recession has a high probability of undergoing further progression even in the presence of good oral hygiene. From an epidemiological point of view, localized facial gingival recessions affect more than 60% of individuals and account for a significant amount of periodontal attachment loss in subjects with good oral hygiene; therefore there is a need for predictable root coverage techniques. Many surgical techniques have been shown to be effective in correcting gingival recession by covering the exposed root with soft tissue; however, the thickness of the gingival tissue over the root surface probably plays an important role in preventing the recurrence of tissue recession. To cover the exposed root surfaces numerous techniques with various modifications have been attempted with the main focus in the recent decades being on complete root coverage. Pedicle grafts are usually considered superior to free soft tissue grafts due to intact blood supply from the donor site. Laterally positioned flap and double papilla grafts are examples of pedicle grafting techniques that obtain advantage of available keratinized tissue from the neighboring teeth. However, there is a risk of developing recession on the donor tooth or in case of double papilla flap, an inadequate coverage due to wound edges being sutured over an avascular surface. This is especially important in cases of thin periodontal phenotype. Sub epithelial connective tissue graft, though considered as a gold standard among the soft tissue grafting techniques involves a second surgical site increasing surgical time, complexity and patient morbidity. . To overcome these limitations, a novel technique is being proposed here.

9. Methodology

i. Study design- This randomized controlled trial will be conducted in the department of Periodontics, Post graduate institute of dental sciences (PGIDS), Rohtak in accordance with the ethical standards outlined in the declaration of Helsinki 1975, as revised in 2013.The study design was approved by Institutional review board, PGIDS, Rohtak and ethical acceptance applied for from the Ethical committee of PGIDS, Rohtak.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NORD group

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.

Group Type: EXPERIMENTAL

novel overlapping rotated double (NORD) flap

Intervention Type: 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.

Sub epithelial connective tissue group

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.

Group Type: ACTIVE_COMPARATOR

novel overlapping rotated double (NORD) flap

Intervention Type: 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.

Interventions

novel overlapping rotated double (NORD) flap

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RITIKA ARORA, M.D.S.

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Dental Sciences, Rohtak

Locations

Post graduate institute of dental sciences

Rohtak, Haryana, India

Countries

India

Other Identifiers

Dr. Ritika Arora perio 2023

Identifier Type: -

Identifier Source: org_study_id