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.
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.
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
- Comparative evaluation of improvement in recession depth, recession width and root coverage percentage after using Conventional Subgingival Instrumentation.
- 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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Test group | Experimental | After 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 Group | Active comparator | After 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.
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
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
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.
- First posted21 Sep 2023
- Study start25 Sep 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anjali Yadav, BDS, Principal investigator, Postgraduate Institute of Dental Sciences Rohtak
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06044727
- Acronym / sponsor ID
- Anjali Periodontics 2022
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 21 Sep 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.
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
- Comparative evaluation of improvement in recession depth, recession width and root coverage percentage after using Conventional Subgingival Instrumentation.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Minimally invasive non surgical periodontal therapyAfter phase 1 therapy, management of RT1 cases will be done with Minimally invasive non surgical periodontal therapy. |
| Control Group | Active comparator | Procedure: Conventional subgingival instrumentationAfter phase 1 therapy, management of RT1 cases will be done with Conventional subgingival instrumentation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Minimally invasive non surgical periodontal therapyusing Magnifying loupes | Procedure or surgery | Test group |
| Conventional subgingival instrumentationConventional subgingival instrumentation | Procedure or surgery | Control Group |
Primary outcome
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
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 5 Sep 2025.
- 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.
Anjali Yadav, BDS principal investigator
Postgraduate 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 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.