Clinical trial NCT05844254: Comparison of Root Coverage Outcomes by NORD Flap Versus Subepithelial Connective Tissue Graft in RT1 Gingival Recession
Official title: Patient Centered Outcomes and Stability of Root Coverage by Novel Overlapping Rotated Double (NORD) Flap as Compared to Sub Epithelial Connective Tissue Graft in Isolated Recession type1 Gingival Recession-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Sub epithelial connective tissue graft
patient centered outcomes
phenotype
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Recession depth
timeFrame: 1month
measure: Change in Recession depth
timeFrame: 6months
measure: Change in Recession depth
timeFrame: 12months
measure: Change in Recession depth
timeFrame: 15months
measure: Root coverage (%)- Change in recession depth/RD at baseline × 100
timeFrame: 1month
measure: Root coverage (%)- change in recession depth/RD at baseline × 100
timeFrame: 6 months
measure: Root coverage (%)-Change in recession depth/RD at baseline × 100
timeFrame: 12months
measure: Root coverage (%)- change in recession depth/RD at baseline × 100
timeFrame: 15months
measure: Visual analog scale
timeFrame: 24 hours after surgery
measure: Visual analog scale
timeFrame: 10 days after surgery
measure: Visual analog scale
timeFrame: 1month
measure: Visual analog scale
timeFrame: 6months
measure: Visual analog scale
timeFrame: 12 months
measure: Visual analog scale
timeFrame: 15 months
measure: Patient centered outcomes
timeFrame: 10 days after surgery
measure: Patient centered outcomes
timeFrame: 1month
Secondary outcomes:
measure: Probing depth
timeFrame: baseline
measure: Probing depth
timeFrame: 1month
measure: Probing depth
timeFrame: 6 months
measure: Probing depth
timeFrame: 12 months
measure: Probing depth
timeFrame: 15 months
measure: Clinical attachment level
timeFrame: baseline
measure: Clinical attachment level
timeFrame: 1month
measure: Clinical attachment level
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 12 months
measure: Clinical attachment level
timeFrame: 15 months
measure: Recession depth- at recipient tooth only
timeFrame: baseline
measure: Recession depth- at recipient tooth only
timeFrame: 1month
measure: Recession depth- at recipient tooth only
timeFrame: 6months
measure: Recession depth- at recipient tooth only
timeFrame: 12months
measure: Recession depth- at recipient tooth only
timeFrame: 15months
measure: Recession width- at recipient tooth only
timeFrame: baseline
measure: Recession width- at recipient tooth only
timeFrame: 1month
measure: Recession width- at recipient tooth only
timeFrame: 6months
measure: Recession width- at recipient tooth only
timeFrame: 12months
measure: Recession width- at recipient tooth only
timeFrame: 15months
measure: width of keratinised gingiva
timeFrame: baseline
measure: Width of keratinised gingiva
timeFrame: 1month
measure: Width of keratinised gingiva
timeFrame: 6months
measure: Width of keratinised gingiva
timeFrame: 12months
measure: Width of keratinised gingiva
timeFrame: 15months
measure: Gingival thickness
timeFrame: baseline
measure: Gingival thickness
timeFrame: 1month
measure: Gingival thickness
timeFrame: 6 months
measure: Gingival thickness
timeFrame: 12 months
measure: Gingival thickness
timeFrame: 15 months
measure: Change in Recession width
timeFrame: 1month
measure: Change in Recession width
timeFrame: 6 months
measure: Change in Recession width
timeFrame: 12 months
measure: Change in Recession width
timeFrame: 15 months
measure: Root coverage-esthetic score
timeFrame: 1month
measure: Root coverage-esthetic score
timeFrame: 6 months
measure: Root coverage-esthetic score
timeFrame: 12 months
measure: Root coverage-esthetic score
timeFrame: 15 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
affiliation: Post Graduate Institute of Dental Sciences, Rohtak
name: RITIKA ARORA, M.D.S.
role: PRINCIPAL_INVESTIGATOR
References: