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Gingival RecessionNCT06044727

MINST Versus Conventional Subgingival Instrumentation In RT1 Gingival Recession

A study testing Minimally invasive non surgical periodontal therapy and Conventional subgingival instrumentation in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Minimally invasive non surgical periodontal therapy and Conventional subgingival instrumentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteIndia
Study dates
25 Sep 2023to 31 Mar 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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Post Graduate Institute of Dental Sciences

    Rohtak, Haryana, 124001

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Minimally invasive non surgical periodontal therapy, Conventional subgingival instrumentation
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally invasive non surgical periodontal therapyProcedure or surgery

    using Magnifying loupes

  • Conventional subgingival instrumentationProcedure or surgery

    Conventional subgingival instrumentation

Study groups in NCT06044727
Study groupRoleWhat they receive
Test groupExperimentalAfter phase 1 therapy, management of RT1 cases will be done with Minimally invasive non surgical periodontal therapy.
Receives: Procedure: Minimally invasive non surgical periodontal therapy
Control GroupActive comparatorAfter phase 1 therapy, management of RT1 cases will be done with Conventional subgingival instrumentation.
Receives: Procedure: Conventional subgingival instrumentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recession Depth

    recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

    Measured: 6 months

  2. Recession Width

    recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

    Measured: 6 months

  3. Root Coverage %

    Will be calculated according to the formula Root Coverage percentage =Recession depth(preop -postop)*100/Recession depth preoperative

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start25 Sep 2023
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

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
Single blind
Who is masked
Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044727
Sponsor's protocol ID
Anjali Periodontics 2022
Status last verified
Aug 2025
First submitted
8 Sep 2023
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Minimally invasive non surgical periodontal therapy and Conventional subgingival instrumentation 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 4 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 5 Sep 2025. 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?

Recession Depth (time frame: 6 months). The study lists 3 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 5 Sep 2025.

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