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

Gingival Recession Clinical Trial

— Recession type  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844254
• Other study ID #: Dr. Ritika Arora perio 2023
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: RITIKA ARORA, M.D.S.
• Phone: 01262-283876
• Email: drritikaarora44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• 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. 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.

Locations

Country	Name	City	State
India	Post graduate institute of dental sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Recession depth	change in recession depth from baseline at 1month will be assessed. The unit of measurement is millimeter.	1month
Primary	Change in Recession depth	change in recession depth from baseline at 6months will be assessed. The unit of measurement is millimeter.	6months
Primary	Change in Recession depth	change in recession depth from baseline at 12months will be assessed. The unit of measurement is millimeter.	12months
Primary	Change in Recession depth	change in recession depth from baseline at 15months will be assessed. The unit of measurement is millimeter.	15months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Patient centered outcomes	All Patient centered outcomes would be recorded in the questionnaire	10 days after surgery
Primary	Patient centered outcomes	All Patient centered outcomes would be recorded in the questionnaire	1month
Secondary	Probing depth	Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.	baseline
Secondary	Probing depth	Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.	1month
Secondary	Probing depth	Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.	6 months
Secondary	Probing depth	Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.	12 months
Secondary	Probing depth	Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.	15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Recession width	Change in recession width would be measured from baseline to 1month.	1month
Secondary	Change in Recession width	Change in recession width would be measured from baseline to 6months.	6 months
Secondary	Change in Recession width	Change in recession width would be measured from baseline to 12months.	12 months
Secondary	Change in Recession width	Change in recession width would be measured from baseline to 15months.	15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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