MINST Versus Conventional Subgingival Instrumentation In RT1 Gingival Recession

• ClinicalTrials.gov Identifier: NCT06044727
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: May 24, 2024
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Information provided by (Responsible Party): Postgraduate Institute of Dental Sciences Rohtak

Tracking Information

• First Submitted Date: September 8, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: May 24, 2024
• Actual Study Start Date: September 1, 2023
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 17, 2023)

• Recession Depth [ Time Frame: 6 months ]
  recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.
• Recession Width [ Time Frame: 6 months ]
  recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
• Root Coverage % [ Time Frame: 6 months ]
  Will be calculated according to the formula Root Coverage percentage =Recession depth(preop -postop)*100/Recession depth preoperative

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MINST Versus Conventional Subgingival Instrumentation In RT1 Gingival Recession
• Official Title: Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using MINST and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession: A Randomized Controlled Clinical Trial
• Brief Summary: Gingival recession is a common condition and its extent and prevalence increase with age. Majority of patients probably present with localized and shallow gingival recession that need a specific treatment because they are susceptible to further apical displacement of gingival margin. So if gingival recession is detected early, removal of causative factors and non surgical treatments initiated then it can prevent more advanced mucogingival defects. Studies have shown that non surgical periodontal therapy including proper oral hygiene instructions, periodic scaling and root planning obtained successful root coverage in shallow gingival recession. Minimal invasive non surgical periodontal therapy (MINST)uses the delicate instruments and magnifying loupes performing periodontal debridement with more effective calculus and biofilm removal and less soft tissue trauma , maintain the tissue architecture, benefit the healing phase, improve the clinical results and increase visibility. There is no study to evaluate efficacy of MINST versus conventional subgingival instrumentation in the restorative capacity of marginal gingival in RT1 gingival recession , so the present study will be conducted to compare and evaluate the efficacy of minimal invasive non surgical periodontal therapy (MINST) and conventional subgingival instrumentation in the restorative capacity of marginal gingiva involving RT1 gingival recession.

Detailed Description

TITLE:

"Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using Minimal Invasive Non-Surgical Periodontal Therapy and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession : A Randomized controlled clinical trial."

RATIONALE:

Gingival recession is a common condition and its extent and prevalence increase with age. Majority of patients probably present with localized and shallow gingival recession that need a specific treatment because they are susceptible to further apical displacement of gingival margin. So if gingival recession is detected early, removal of causative factors and non surgical treatment initiated then it can prevent more advanced mucogingival defects. Studies have shown that non surgical periodontal therapy including proper oral hygiene instructions, periodic scaling and root planning obtained successful root coverage in shallow gingival recession. Minimal invasive non surgical periodontal therapy (MINST)uses the delicate instruments and magnifying loupes performing periodontal debridement with more effective calculus and biofilm removal and less soft tissue trauma , maintain the tissue architecture, benefit the healing phase, improve the clinical results and increase visibility. There is no study to evaluate efficacy of MINST versus conventional subgingival instrumentation in the restorative capacity of marginal gingival in RT1 gingival recession , so the present study will evaluate the same.

AIM:

To compare and evaluate the efficacy of minimal invasive non surgical periodontal therapy (MINST) and conventional subgingival instrumentation in the restorative capacity of marginal gingiva involving RT1 gingival recession.

OBJECTIVES:

PRIMARY OBJECTIVE

1. Comparative evaluation of improvement in recession depth, recession width and root coverage percentage after using Conventional Subgingival Instrumentation.
2. Comparative evaluation of improvement in recession depth, recession width and root coverage percentage after using MINST.

SECONDARY OBJECTIVE To assess the improvement in other clinical parameters which include- Clinical attachment level (CAL), Probing Pocket Depth (PPD), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI),Gingival thickness (GT), Keratinized tissue width (KTW) and Visual analog scale for patient reported outcome of pain and hypersensitivity.

SETTING:

Department of Periodontics and Oral Implantology, PGIDS, Rohtak, Haryana.

STUDY DESIGN:

Randomized controlled clinical trial

TIME FRAME:

12-14 months

POPULATION:

Systemically healthy patients with RT1 gingival recession will be recruited in the study from out patient department of Periodontology. Recruitment of the patients for the study will be based on eligibility criteria after obtaining informed and written consent.

MATERIAL AND METHOD:

Systemically healthy patients having RT1 gingival recession will be assigned into control group (Conventional subgingival instrumentation) and test group( MINST). One group will be treated with Conventional subgingival instrumentation and other group will be treated with MINST. All the patients will be recalled twice in 1st and 2nd month followed by 3 months and 6 months for reevaluation. Standardized oral hygiene instructions will be imparted and reinforced at each appointment. Minimal Invasive non surgical periodontal therapy(MINST) and conventional subgingival instrumentation will be performed at follow up visits if required.

STATISTICAL ANALYSIS:

Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution, inter group comparison will be done by using Independent T test and paired T test will be use for intragroup comparison and if non normal distribution of data, inter group comparison will be done by Mann-whitney U test and intragroup by signed rank test . The Chi square test will be applied to analyze categoric data. Correlation and association between predictors and dependent variables will be analyzed by correlation analysis and regression analysis.

RESEARCH QUESTION:

Does the use of minimal invasive non surgical periodontal therapy enhances the restorative capacity of marginal gingiva of RT1 gingival recession than conventional subgingival instrumentation.

P- POPULATION: systemically healthy patients with RT1 gingival recession

I- INTERVENTION: Conventional subgingival instrumentation with RT1 gingival recession

C-COMPARATOR: Minimal invasive non surgical periodontal therapy with RT1 gingival recession O- OUTCOME: Changes in recession depth, recession width and root coverage percentage.

T- TIME: 12-14 months

F- Feasibility: adequate sample size, infrastructure, time , study design.

I- Interesting: as it will be using minimal invasive non surgical periodontal therapy in RT1 gingival recession.

N- Novelty: no study was found in literature comparing the effects of minimal invasive non surgical periodontal therapy and conventional subgingival instrumentation in RT1 shallow gingival recession.

E- Ethical: Ethical

R- Relevant: exploring the efficacy of minimal invasive non surgical periodontal therapy and conventional subgingival instrumentation in RT1 gingival recession.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Gingival Recession

Intervention

• Procedure: Minimally invasive non surgical periodontal therapy
  using Magnifying loupes
• Procedure: Conventional subgingival instrumentation
  Conventional subgingival instrumentation

Study Arms

• Experimental: Test group
  After phase 1 therapy, management of RT1 cases will be done with Minimally invasive non surgical periodontal therapy.
  Intervention: Procedure: Minimally invasive non surgical periodontal therapy
• Active Comparator: Control Group
  After phase 1 therapy, management of RT1 cases will be done with Conventional subgingival instrumentation.
  Intervention: Procedure: Conventional subgingival instrumentation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 17, 2023): 54
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2024
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Gingival Recession Type 1(RT1) by Cairo et al 2011in esthetic zone including maxillary and mandibular anteriors and premolars, otherwise systemically healthy
2. Gingival Recession ≤3mm associated with plaque induced inflammation and identifiable CEJ
3. Age 20 years to 50 years
4. Providing a written and verbal informed consent.

Exclusion Criteria:

1. Patient with systemic disease that can influence the outcome of therapy.
2. Pregnant females or on oral contraceptive pills or hormone replacement therapy.
3. Smokers and patients undergoing orthodontic therapy
4. Physically and mentally impaired patients.
5. Non vital, mal-positioned tooth
6. Presence of cervical abrasions or restorations in the area
7. Previous history of periodontal surgery on the involved sites.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Dr. Nishi Tanwar, MDS; 8368126310; nsh_tanwar@yahoo.com

• Listed Location Countries: India

Administrative Information

• NCT Number: NCT06044727
• Other Study ID Numbers: Anjali Periodontics 2022
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
• Original Responsible Party: Same as current
• Current Study Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anjali Yadav, BDS; Postgraduate Institute of Dental Sciences Rohtak

• PRS Account: Postgraduate Institute of Dental Sciences Rohtak
• Verification Date: May 2024