Tooth MobilityNCT06436729
Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth
A study testing Splinting and MINST alone in people with Tooth Mobility and Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Mobility, Periodontitis
- What is being tested?
- Splinting and MINST alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2024to 31 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age ≥ 18 years.
- Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) ≥ 5 mm and a relative alveolar bone loss (ABL) of ≥ 50% at the affected tooth.
- Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1
Who cannot join
- Patients with anterior cross bite
- Bruxism or signs of parafunction
- Implant in Anterior teeth
- Any active periodontal therapy in last 1 year
- Mobility of teeth due to acute trauma
- Pulpal or periapical pathology in anterior teeth
Show all 9Show fewer
- Patient requiring any emergency dental procedure
- Patient on antibiotic therapy in last 1 month
- If patient want to undergo surgical treatment for management of periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. The main questions it aims to answer are:
- Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters ?
- Does splinting provide additional benefit to MINST alone for improving OHRQoL ?
Read the detailed description
The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss (CAL) and alveolar bone loss (ABL) and/or due to secondary occlusal trauma.
Tooth splinting continues to be a topic of controversy. It remains one of the most poorly understood and controversial areas of dental therapy.
Minimally invasive non-surgical periodontal therapy (MINST) has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices .
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) following Minimally Invasive Non-Surgical Therapy (MINST), both with and without splinting, in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth.
Patients will be screened and enrolled based on specific eligibility criteria. Baseline measurements of outcome parameters will be taken, followed by supragingival scaling, and patients will be recalled after one week.
During the subsequent visit, patients will be randomized into either the test group or the control group. The test group will receive MINST along with splinting of the mobile anterior teeth, while the control group will receive MINST alone.
Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements.
- Conditions
- Tooth Mobility, Periodontitis
- Being tested
- Splinting, MINST alone
- Keywords
- Splinting, OHRQoL, MINST
- Medical subject headings
- Tooth Mobility, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintingProcedure or surgery
The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices
MINST aloneProcedure or surgery
Minimally invasive non surgical therapy alone
| Study group | Role | What they receive |
|---|---|---|
| MINST with Splinting | Experimental | Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth Receives: Procedure: Splinting |
| MINST without Splinting | Active comparator | Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth Receives: Procedure: MINST alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Clinical Attachment Level (CAL)
Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket.
Measured: 12 - 14 months
Changes in Oral Health Related Quality of Life (OHRQoL)
OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP)
Measured: 12 - 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jun 2024
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth MobilityStudies 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
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navi Bansal, BDS, Principal investigator, PGIDS, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436729
- Sponsor's protocol ID
- Navi Bansal Perio 24/39
- Status last verified
- May 2026
- First submitted
- 24 May 2024
- 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
- Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06436729
- Acronym / sponsor ID
- Navi Bansal Perio 24/39
- Conditions
- Tooth Mobility, Periodontitis
- Keywords
- Splinting, OHRQoL, MINST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 31 May 2024 (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.
The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. The main questions it aims to answer are:
- Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters ?
- Does splinting provide additional benefit to MINST alone for improving OHRQoL ?
Detailed description
The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss (CAL) and alveolar bone loss (ABL) and/or due to secondary occlusal trauma.
Tooth splinting continues to be a topic of controversy. It remains one of the most poorly understood and controversial areas of dental therapy.
Minimally invasive non-surgical periodontal therapy (MINST) has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices .
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) following Minimally Invasive Non-Surgical Therapy (MINST), both with and without splinting, in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth.
Patients will be screened and enrolled based on specific eligibility criteria. Baseline measurements of outcome parameters will be taken, followed by supragingival scaling, and patients will be recalled after one week.
During the subsequent visit, patients will be randomized into either the test group or the control group. The test group will receive MINST along with splinting of the mobile anterior teeth, while the control group will receive MINST alone.
Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINST with Splinting | Experimental | Procedure: SplintingMinimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth |
| MINST without Splinting | Active comparator | Procedure: MINST aloneMinimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age ≥ 18 years.
- Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) ≥ 5 mm and a relative alveolar bone loss (ABL) of ≥ 50% at the affected tooth.
- Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1
Key exclusion criteria (9 listed)
- Patients with anterior cross bite
- Bruxism or signs of parafunction
- Implant in Anterior teeth
- Any active periodontal therapy in last 1 year
- Mobility of teeth due to acute trauma
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 |
|---|---|---|
| SplintingThe joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices | Procedure or surgery | MINST with Splinting |
| MINST aloneMinimally invasive non surgical therapy alone | Procedure or surgery | MINST without Splinting |
Primary outcome
Changes in Clinical Attachment Level (CAL)
Time frame: 12 - 14 months
Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket.
Changes in Oral Health Related Quality of Life (OHRQoL)
Time frame: 12 - 14 months
OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP)
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
Related trials for Tooth Mobility
Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Recruiting
Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement
Tooth Mobility, Injectable Platelet-rich Fibrin
Active, not recruitingObservational study
Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
Periodontitis, Tooth Mobility
Not yet recruitingObservational study
Physical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment
Charcot-Marie-Tooth Disease, Type IA, Peripheral Neuropathy Hereditary
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.
Navi Bansal, BDS principal investigator
PGIDS, 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 Splinting and MINST alone in people with Tooth Mobility and Periodontitis, 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 3 inclusion and 9 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?
Changes in Clinical Attachment Level (CAL) (time frame: 12 - 14 months). The study lists 2 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.