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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: novel overlapping rotated double (NORD) flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NORD group<br>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<br>* 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. Group 1(NORD group)- Patients treated with NORD flap 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.<br>|
| Active Comparator: Sub epithelial connective tissue group<br>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<br>* 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. Group 1(NORD group)- Patients treated with NORD flap 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth. | baseline | 
| Probing depth | Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth. | 1month | 
| Probing depth | Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth. | 6 months | 
| Probing depth | Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth. | 12 months | 
| Probing depth | Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth. | 15 months | 
| Clinical attachment level | Probing depth (in millimeter) would be measured from cemento-enamel junction to base of the pocket at six sites per tooth. | baseline | 
| Clinical attachment level | Probing depth (in millimeter) would be measured from cemento-enamel junction to base of the pocket at six sites per tooth. | 1month | 
| Clinical attachment level | Probing depth (in millimeter) would be measured from cemento-enamel junction to base of the pocket at six sites per tooth. | 6 months | 
| Clinical attachment level | Probing depth (in millimeter) would be measured from cemento-enamel junction to base of the pocket at six sites per tooth. | 12 months | 
| Clinical attachment level | Probing depth (in millimeter) would be measured from cemento-enamel junction to base of the pocket at six sites per tooth. | 15 months | 
| Recession depth- at recipient tooth only | recession depth (in millimeter) would be measured as a distance from the cemento-enamel junction to the most apical point of the buccal gingival margin | baseline | 
| Recession depth- at recipient tooth only | recession depth (in millimeter) would be measured as a distance from the cemento-enamel junction to the most apical point of the buccal gingival margin | 1month | 
| Recession depth- at recipient tooth only | recession depth (in millimeter) would be measured as a distance from the cemento-enamel junction to the most apical point of the buccal gingival margin | 6months | 
| Recession depth- at recipient tooth only | recession depth (in millimeter) would be measured as a distance from the cemento-enamel junction to the most apical point of the buccal gingival margin | 12months | 
| Recession depth- at recipient tooth only | recession depth (in millimeter) would be measured as a distance from the cemento-enamel junction to the most apical point of the buccal gingival margin | 15months | 
| Recession width- at recipient tooth only | recession width (in millimeter) would be measured by placing the periodontal probe horizontally at the most apical point of buccal cemento-enamel junction. The distance from the gingival margin mesial to a point distal of the recession will be measured. | baseline | 
| Recession width- at recipient tooth only | recession width (in millimeter) would be measured by placing the periodontal probe horizontally at the most apical point of buccal cemento-enamel junction. The distance from the gingival margin mesial to a point distal of the recession will be measured. | 1month | 
| Recession width- at recipient tooth only | recession width (in millimeter) would be measured by placing the periodontal probe horizontally at the most apical point of buccal cemento-enamel junction. The distance from the gingival margin mesial to a point distal of the recession will be measured. | 6months | 
| Recession width- at recipient tooth only | recession width (in millimeter) would be measured by placing the periodontal probe horizontally at the most apical point of buccal cemento-enamel junction. The distance from the gingival margin mesial to a point distal of the recession will be measured. | 12months | 
| Recession width- at recipient tooth only | recession width (in millimeter) would be measured by placing the periodontal probe horizontally at the most apical point of buccal cemento-enamel junction. The distance from the gingival margin mesial to a point distal of the recession will be measured. | 15months | 
| width of keratinised gingiva | Distance would be measured from gingival margin to muco-gingival junction at mid-buccal site to calculate width of keratinized gingiva. From the calculated width of keratinized gingiva, subtract the Probing depth at mid-buccal site. | baseline | 
| Width of keratinised gingiva | Distance would be measured from gingival margin to muco-gingival junction at mid-buccal site to calculate width of keratinized gingiva. From the calculated width of keratinized gingiva, subtract the Probing depth at mid-buccal site. | 1month | 
| Width of keratinised gingiva | Distance would be measured from gingival margin to muco-gingival junction at mid-buccal site to calculate width of keratinized gingiva. From the calculated width of keratinized gingiva, subtract the Probing depth at mid-buccal site. | 6months | 
| Width of keratinised gingiva | Distance would be measured from gingival margin to muco-gingival junction at mid-buccal site to calculate width of keratinized gingiva. From the calculated width of keratinized gingiva, subtract the Probing depth at mid-buccal site. | 12months | 
| Width of keratinised gingiva | Distance would be measured from gingival margin to muco-gingival junction at mid-buccal site to calculate width of keratinized gingiva. From the calculated width of keratinized gingiva, subtract the Probing depth at mid-buccal site. | 15months | 
| Gingival thickness | Gingival thickness will be measured 1.0mm apical to gingival margin using an injection needle, perpendicular to tissue surface, and a silicon stop over gingival surface. The silicon disc stop will be placed in tight contact with soft tissue. After needle removal, the distance between needle tip and silicon stop will be estimated using a digital caliper with 0.01mm of accuracy. | baseline | 
| Gingival thickness | Gingival thickness will be measured 1.0mm apical to gingival margin using an injection needle, perpendicular to tissue surface, and a silicon stop over gingival surface. The silicon disc stop will be placed in tight contact with soft tissue. After needle removal, the distance between needle tip and silicon stop will be estimated using a digital caliper with 0.01mm of accuracy. | 1month | 
| Gingival thickness | Gingival thickness will be measured 1.0mm apical to gingival margin using an injection needle, perpendicular to tissue surface, and a silicon stop over gingival surface. The silicon disc stop will be placed in tight contact with soft tissue. After needle removal, the distance between needle tip and silicon stop will be estimated using a digital caliper with 0.01mm of accuracy. | 6 months | 
| Gingival thickness | Gingival thickness will be measured 1.0mm apical to gingival margin using an injection needle, perpendicular to tissue surface, and a silicon stop over gingival surface. The silicon disc stop will be placed in tight contact with soft tissue. After needle removal, the distance between needle tip and silicon stop will be estimated using a digital caliper with 0.01mm of accuracy. | 12 months | 
| Gingival thickness | Gingival thickness will be measured 1.0mm apical to gingival margin using an injection needle, perpendicular to tissue surface, and a silicon stop over gingival surface. The silicon disc stop will be placed in tight contact with soft tissue. After needle removal, the distance between needle tip and silicon stop will be estimated using a digital caliper with 0.01mm of accuracy. | 15 months | 
| Change in Recession width | Change in recession width would be measured from baseline to 1month. | 1month | 
| Change in Recession width | Change in recession width would be measured from baseline to 6months. | 6 months | 
| Change in Recession width | Change in recession width would be measured from baseline to 12months. | 12 months | 
| Change in Recession width | Change in recession width would be measured from baseline to 15months. | 15 months | 
| Root coverage-esthetic score | According to Root coverage-esthetic score system 5 variables will be assessed. The variables are: level of gingival margin, marginal tissue contour, soft tissue texture, muco-gingival junction alignment, gingival colour. A score of 0,3, or 6 will be used for the evaluation of gingival margin position, whereas a score of 0-1 will be used for each of the other variables. The highest and best aesthetic score to be achieved for complete root coverage is 10. | 1month | 
| Root coverage-esthetic score | According to Root coverage-esthetic score system 5 variables will be assessed. The variables are: level of gingival margin, marginal tissue contour, soft tissue texture, muco-gingival junction alignment, gingival colour. A score of 0,3, or 6 will be used for the evaluation of gingival margin position, whereas a score of 0-1 will be used for each of the other variables. The highest and best aesthetic score to be achieved for complete root coverage is 10. | 6 months | 
| Root coverage-esthetic score | According to Root coverage-esthetic score system 5 variables will be assessed. The variables are: level of gingival margin, marginal tissue contour, soft tissue texture, muco-gingival junction alignment, gingival colour. A score of 0,3, or 6 will be used for the evaluation of gingival margin position, whereas a score of 0-1 will be used for each of the other variables. The highest and best aesthetic score to be achieved for complete root coverage is 10. | 12 months | 
| Root coverage-esthetic score | According to Root coverage-esthetic score system 5 variables will be assessed. The variables are: level of gingival margin, marginal tissue contour, soft tissue texture, muco-gingival junction alignment, gingival colour. A score of 0,3, or 6 will be used for the evaluation of gingival margin position, whereas a score of 0-1 will be used for each of the other variables. The highest and best aesthetic score to be achieved for complete root coverage is 10. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sub epithelial connective tissue graft, patient centered outcomes, phenotype