Gingival RecessionRecession typeNCT05844254
Comparison of Root Coverage Outcomes by NORD Flap Versus Subepithelial Connective Tissue Graft in RT1 Gingival Recession
A study testing novel overlapping rotated double (NORD) flap in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- novel overlapping rotated double (NORD) flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- 2 Apr 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Methodology
- 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
- Being tested
- novel overlapping rotated double (NORD) flap
- Keywords
- Sub epithelial connective tissue graft, patient centered outcomes, phenotype
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel overlapping rotated double (NORD) flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: novel overlapping rotated double (NORD) flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recession depth
change in recession depth from baseline at 1month will be assessed. The unit of measurement is millimeter.
Measured: 1month
Change in Recession depth
change in recession depth from baseline at 6months will be assessed. The unit of measurement is millimeter.
Measured: 6months
Change in Recession depth
change in recession depth from baseline at 12months will be assessed. The unit of measurement is millimeter.
Measured: 12months
Change in Recession depth
change in recession depth from baseline at 15months will be assessed. The unit of measurement is millimeter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months
Patient centered outcomes
All Patient centered outcomes would be recorded in the questionnaire
Measured: 10 days after surgery
Patient centered outcomes
All Patient centered outcomes would be recorded in the questionnaire
Measured: 1month
Secondary outcomes (38)
Probing depth
Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.
Measured: baseline
Probing depth
Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.
Measured: 1month
Probing depth
Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.
Measured: 6 months
Probing depth
Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.
Measured: 12 months
Probing depth
Probing depth (in millimeter) would be measured from gingival margin to the base of pocket at six sites per tooth.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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.
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.
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months
Change in Recession width
Change in recession width would be measured from baseline to 1month.
Measured: 1month
Change in Recession width
Change in recession width would be measured from baseline to 6months.
Measured: 6 months
Change in Recession width
Change in recession width would be measured from baseline to 12months.
Measured: 12 months
Change in Recession width
Change in recession width would be measured from baseline to 15months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start2 Apr 2023
- Primary completion1 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RITIKA ARORA, M.D.S., Principal investigator, Post Graduate Institute of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844254
- Sponsor's protocol ID
- Dr. Ritika Arora perio 2023
- Acronym
- Recession type
- Status last verified
- May 2026
- First submitted
- 1 Feb 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844254
- Acronym / sponsor ID
- Recession type / Dr. Ritika Arora perio 2023
- Conditions
- Gingival Recession
- Keywords
- Sub epithelial connective tissue graft, patient centered outcomes, phenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Methodology
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NORD group | Experimental | Procedure: novel overlapping rotated double (NORD) flapAfter 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. |
| Sub epithelial connective tissue group | Active comparator | Procedure: novel overlapping rotated double (NORD) flapAfter 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Age 18-45 years
Key exclusion criteria (7 listed)
- • Patients with a history of any systemic condition that might alter the course of disease and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel overlapping rotated double (NORD) flapAfter 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. | Procedure or surgery | NORD group, Sub epithelial connective tissue group |
Primary outcome
Change in Recession depth
Time frame: 1month
change in recession depth from baseline at 1month will be assessed. The unit of measurement is millimeter.
Change in Recession depth
Time frame: 6months
change in recession depth from baseline at 6months will be assessed. The unit of measurement is millimeter.
Change in Recession depth
Time frame: 12months
change in recession depth from baseline at 12months will be assessed. The unit of measurement is millimeter.
Change in Recession depth
Time frame: 15months
change in recession depth from baseline at 15months will be assessed. The unit of measurement is millimeter.
Root coverage (%)- Change in recession depth/RD at baseline × 100
Time frame: 1month
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.
Root coverage (%)- change in recession depth/RD at baseline × 100
Time frame: 6 months
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.
Root coverage (%)-Change in recession depth/RD at baseline × 100
Time frame: 12months
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.
Root coverage (%)- change in recession depth/RD at baseline × 100
Time frame: 15months
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.
Visual analog scale
Time frame: 24 hours after surgery
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.
Visual analog scale
Time frame: 10 days after surgery
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.
Visual analog scale
Time frame: 1month
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.
Visual analog scale
Time frame: 6months
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.
Visual analog scale
Time frame: 12 months
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.
Visual analog scale
Time frame: 15 months
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.
Patient centered outcomes
Time frame: 10 days after surgery
All Patient centered outcomes would be recorded in the questionnaire
Patient centered outcomes
Time frame: 1month
All Patient centered outcomes would be recorded in the questionnaire
38 secondary outcomes
Probing depth
Time frame: baseline
Probing depth
Time frame: 1month
Probing depth
Time frame: 6 months
Probing depth
Time frame: 12 months
Probing depth
Time frame: 15 months
Clinical attachment level
Time frame: baseline
Clinical attachment level
Time frame: 1month
Clinical attachment level
Time frame: 6 months
Clinical attachment level
Time frame: 12 months
Clinical attachment level
Time frame: 15 months
Recession depth- at recipient tooth only
Time frame: baseline
Recession depth- at recipient tooth only
Time frame: 1month
Recession depth- at recipient tooth only
Time frame: 6months
Recession depth- at recipient tooth only
Time frame: 12months
Recession depth- at recipient tooth only
Time frame: 15months
Recession width- at recipient tooth only
Time frame: baseline
Recession width- at recipient tooth only
Time frame: 1month
Recession width- at recipient tooth only
Time frame: 6months
Recession width- at recipient tooth only
Time frame: 12months
Recession width- at recipient tooth only
Time frame: 15months
width of keratinised gingiva
Time frame: baseline
Width of keratinised gingiva
Time frame: 1month
Width of keratinised gingiva
Time frame: 6months
Width of keratinised gingiva
Time frame: 12months
Width of keratinised gingiva
Time frame: 15months
Gingival thickness
Time frame: baseline
Gingival thickness
Time frame: 1month
Gingival thickness
Time frame: 6 months
Gingival thickness
Time frame: 12 months
Gingival thickness
Time frame: 15 months
Change in Recession width
Time frame: 1month
Change in Recession width
Time frame: 6 months
Change in Recession width
Time frame: 12 months
Change in Recession width
Time frame: 15 months
Root coverage-esthetic score
Time frame: 1month
Root coverage-esthetic score
Time frame: 6 months
Root coverage-esthetic score
Time frame: 12 months
Root coverage-esthetic score
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RITIKA ARORA, M.D.S. principal investigator
Post Graduate Institute of Dental Sciences, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel overlapping rotated double (NORD) flap in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Recession depth (time frame: 1month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.