Motivational InterviewingNCT07618533
Motivational Interviewing and Subgingival Instrumentation Outcomes in Periodontitis
A study testing Motivational Interviewing and Oral hygiene instructions in people with Motivational Interviewing and Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Motivational Interviewing (MI) represents a patient centered counselling approach designed to facilitate behaviour change by guiding patients through the exploration and resolution of ambivalence toward positive health actions. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Motivational Interviewing, Periodontitis, Oral Hygiene
- What is being tested?
- Motivational Interviewing and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jun 2026to 27 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy Patients with age group 30-50 years diagnosed with (Stage I-III) periodontitis.
Who cannot join
- Systemic diseases that may affect periodontal disease progression or outcome of treatment
- Patients on long term antibiotics
- Pregnant and lactating women
- Female patients with history of menopause
- Current orthodontic treatment or planning to undergo orthodontic treatment during study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001
Dr. Rajinder Kumar Sharma, MDS, +919416358222, rksharmamds@yahoo.in
About this study
Official title: Effect of Motivational Interviewing on the Outcomes of Subgingival Instrumentation in Patients With Periodontitis
Motivational Interviewing (MI) represents a patient centered counselling approach designed to facilitate behaviour change by guiding patients through the exploration and resolution of ambivalence toward positive health actions. Adapting OARS microskills (open ended questions fostering dialogue, affirmations building self-efficacy, reflective listening mirroring emotions, summarization making commitments) intertwined with the RULE framework (resisting the righting reflex, understanding personal motivations, empathic listening, empowering autonomy) helps cultivate patient's intrinsic motivation for sustained oral hygiene adherence. It effectively resolves ambivalence toward plaque control behaviours essential for periodontitis management. Grounded in MI's core spirit of equal partnership, evocation of inner values, acceptance and compassionate support, this approach fosters long term adherence to treatment. This is in contrast to oral hygiene instructions that typically employ a directive advice giving method, where clinicians provide patients with prescriptive guidance on maintaining optimal oral hygiene practices. Periodontitis staging, as defined by the 2017 World Workshop classification, delineates disease severity (Stages I-III), complexity of management, and extent of involvement, while grading (A-C) offers a prognostic indicator of the risk for future progression based on factors such as rate of advancement and responsiveness to therapy. Integrating motivational interviewing (MI) with periodontitis staging and grading creates a structured framework from diagnosis to patient centered action, enhancing adherence to stage specific treatment plans. This study seeks to investigate the influence of MI on Clinical outcomes, Patient motivation, Patient related outcomes and Patient's Self-efficacy in oral hygiene following subgingival instrumentation among patients stratified by periodontitis stage. By doing so, it aims to explore the potential of behavior change interventions to yield not only clinical improvements but also broader health benefits in the management of periodontitis.
Read the detailed description
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus. Periodontal disease can cause physical discomfort and contribute to functional limitations, which in turn affect psychological well-being and self-esteem. Periodontitis poses a significant public health challenge due to its high prevalence and potential to cause tooth loss, disability, and impairments in chewing function and aesthetics. Sustaining periodontal health demands patient led interventions, including self-care practices and attention to lifestyle factors. Interventions based on health behaviour change models to target improvements in patient self-efficacy, enhances treatment adherence and increases the frequency of brushing and flossing. Behavioural determinants related to impaired periodontal health includes inadequate plaque control measures, smoking habits, sedentary living, excess alcohol, stress and detrimental eating behaviours. Although subject to modification, these lifestyle factors still generate substantial disease prevalence and economic demands globally.Motivational interviewing (MI) for periodontology is recommended by 1st European workshop on periodontal education, to enhance patient's intrinsic motivation. MI has been found to be effective in treating a broad range of health-related lifestyle problems, such as substance abuse, obesity, diabetes management, tobacco cessation, and poor adherence to medication regimens.
MI was first described in 1983, by Psychologist William R Miller. It was initially developed as a short term approach for problem drinking. Motivational Interviewing is a person centered counselling approach for eliciting behaviour change by helping clients to explore and resolve ambivalence. MI works by activating patients' own motivation for change and adherence to treatment.
The effective implementation of Motivational Interviewing (MI) depends on the practitioner's expertise in essential micro skills (OARS) i.e, Open-ended questions which promotes conversation between the clinician and patient encouraging patient to speak and the clinician listens; Affirmations that recognize the challenges in behaviour change while promoting patient self-efficacy by validation of their strengths; Reflective listening accounts for understanding patient's expressed thoughts and emotions and Summarization that illustrates the clinician's active listening to the patient and offers a brief outline of the discussion, while also aiding in addressing ambivalence. These OARS skills are used within "RULE" framework i.e- Resisting the righting reflex by suppressing the urge to correct or direct the patients as arguing for change evokes counter arguments from patients. Understanding patient's own motivation by exploring patients' perceptions about their current situations and their own reasons for change rather than clinician imposing their own. Listening to patient with empathy over informing to grasp the patient's perspective and help resolve ambivalence about change. Empowering the patient to support their autonomy and self-efficacy enabling them to envision and pursue solutions.
Given the importance of Patient's education and awareness about their periodontal health, this study seeks to investigate the impact of MI on the outcomes of subgingival instrumentation in patients with periodontitis. It also evaluates MI's effects on patient-reported outcomes, motivation, and self-efficacy. By addressing these gaps, the study aims to offer evidence based insights for enhancing periodontal therapy.
- Conditions
- Motivational Interviewing, Periodontitis, Oral Hygiene
- Being tested
- Motivational Interviewing, Oral hygiene instructions
- Keywords
- Motivational interviewing, Periodontitis staging and grading, Treatment adherence
- Medical subject headings
- Periodontitis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
A single individual motivational interviewing session will be delivered to each patient at baseline and 1 month
Oral hygiene instructionsBehavioural
Oral hygiene instructions will be provided to each patient at baseline and at 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Motivation Interviewing | Experimental | Participants will receive a single session of motivational interviewing Receives: Behavioral: Motivational Interviewing |
| Oral hygiene Instructions | Active comparator | General oral hygiene instructions will be given to all the patients in control group at baseline and at 1 month Receives: Behavioral: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dental Treatment Motivation Scale (DTMS)
The Dental Treatment Motivation Scale (DTMS)19 questionnaire will be used to measure each participant's level of motivation. . The scale has a total of 15 items, which assess intrinsic (seven questions) and extrinsic motivation (eight questions). Answers provided on a scale are from 1 to 5, where 1 = "strongly disagree" and 5 = "strongly agree." Patients will complete the questionnaire at the 3, 6 month follow-up appointment after periodontal treatment. Higher score indicates higher level of patient motivation towards dental treatment.
Measured: Baseline, 3 month, 6 month
Patient related outcome Measure
The Oral Health Impact Profile-14 (OHIP-14) questionnaire will be used to measure each participant's Oral Health related quality of life (OHRQoL). It evaluates 14 questions under seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (1=never to 5=very often) with total scores ranging from 0-56 (higher scores indicate worse Oral health quality of life).
Measured: Baseline, 3 month, 6 month
Evaluation of Patient's Self Efficacy
The Oral Hygiene Related Self Efficacy Scale (OHSE) questionnaire will be used for assessing self-efficacy. It includes 19 items rated on 4 point Likert scale from (1) Completely confident not to (4) Completely confident. Higher scores indicate stronger belief in one's ability to maintain oral health, correlating with better hygiene practices and treatment outcomes.
Measured: Baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion27 Jun 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational InterviewingStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Rajinder Kumar Sharma, MDS, Study director, Post Graduate Institute Of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618533
- Sponsor's protocol ID
- Akanksha Mahajan Perio 26/57
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interviewing on the Outcomes of Subgingival Instrumentation in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07618533
- Acronym / sponsor ID
- Akanksha Mahajan Perio 26/57
- Conditions
- Motivational Interviewing, Periodontitis, Oral Hygiene
- Keywords
- Motivational interviewing, Periodontitis staging and grading, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (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.
Motivational Interviewing (MI) represents a patient centered counselling approach designed to facilitate behaviour change by guiding patients through the exploration and resolution of ambivalence toward positive health actions. Adapting OARS microskills (open ended questions fostering dialogue, affirmations building self-efficacy, reflective listening mirroring emotions, summarization making commitments) intertwined with the RULE framework (resisting the righting reflex, understanding personal motivations, empathic listening, empowering autonomy) helps cultivate patient's intrinsic motivation for sustained oral hygiene adherence. It effectively resolves ambivalence toward plaque control behaviours essential for periodontitis management. Grounded in MI's core spirit of equal partnership, evocation of inner values, acceptance and compassionate support, this approach fosters long term adherence to treatment. This is in contrast to oral hygiene instructions that typically employ a directive advice giving method, where clinicians provide patients with prescriptive guidance on maintaining optimal oral hygiene practices. Periodontitis staging, as defined by the 2017 World Workshop classification, delineates disease severity (Stages I-III), complexity of management, and extent of involvement, while grading (A-C) offers a prognostic indicator of the risk for future progression based on factors such as rate of advancement and responsiveness to therapy. Integrating motivational interviewing (MI) with periodontitis staging and grading creates a structured framework from diagnosis to patient centered action, enhancing adherence to stage specific treatment plans. This study seeks to investigate the influence of MI on Clinical outcomes, Patient motivation, Patient related outcomes and Patient's Self-efficacy in oral hygiene following subgingival instrumentation among patients stratified by periodontitis stage. By doing so, it aims to explore the potential of behavior change interventions to yield not only clinical improvements but also broader health benefits in the management of periodontitis.
Detailed description
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus. Periodontal disease can cause physical discomfort and contribute to functional limitations, which in turn affect psychological well-being and self-esteem. Periodontitis poses a significant public health challenge due to its high prevalence and potential to cause tooth loss, disability, and impairments in chewing function and aesthetics. Sustaining periodontal health demands patient led interventions, including self-care practices and attention to lifestyle factors. Interventions based on health behaviour change models to target improvements in patient self-efficacy, enhances treatment adherence and increases the frequency of brushing and flossing. Behavioural determinants related to impaired periodontal health includes inadequate plaque control measures, smoking habits, sedentary living, excess alcohol, stress and detrimental eating behaviours. Although subject to modification, these lifestyle factors still generate substantial disease prevalence and economic demands globally.Motivational interviewing (MI) for periodontology is recommended by 1st European workshop on periodontal education, to enhance patient's intrinsic motivation. MI has been found to be effective in treating a broad range of health-related lifestyle problems, such as substance abuse, obesity, diabetes management, tobacco cessation, and poor adherence to medication regimens.
MI was first described in 1983, by Psychologist William R Miller. It was initially developed as a short term approach for problem drinking. Motivational Interviewing is a person centered counselling approach for eliciting behaviour change by helping clients to explore and resolve ambivalence. MI works by activating patients' own motivation for change and adherence to treatment.
The effective implementation of Motivational Interviewing (MI) depends on the practitioner's expertise in essential micro skills (OARS) i.e, Open-ended questions which promotes conversation between the clinician and patient encouraging patient to speak and the clinician listens; Affirmations that recognize the challenges in behaviour change while promoting patient self-efficacy by validation of their strengths; Reflective listening accounts for understanding patient's expressed thoughts and emotions and Summarization that illustrates the clinician's active listening to the patient and offers a brief outline of the discussion, while also aiding in addressing ambivalence. These OARS skills are used within "RULE" framework i.e- Resisting the righting reflex by suppressing the urge to correct or direct the patients as arguing for change evokes counter arguments from patients. Understanding patient's own motivation by exploring patients' perceptions about their current situations and their own reasons for change rather than clinician imposing their own. Listening to patient with empathy over informing to grasp the patient's perspective and help resolve ambivalence about change. Empowering the patient to support their autonomy and self-efficacy enabling them to envision and pursue solutions.
Given the importance of Patient's education and awareness about their periodontal health, this study seeks to investigate the impact of MI on the outcomes of subgingival instrumentation in patients with periodontitis. It also evaluates MI's effects on patient-reported outcomes, motivation, and self-efficacy. By addressing these gaps, the study aims to offer evidence based insights for enhancing periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivation Interviewing | Experimental | Behavioral: Motivational InterviewingParticipants will receive a single session of motivational interviewing |
| Oral hygiene Instructions | Active comparator | Behavioral: Oral hygiene instructionsGeneral oral hygiene instructions will be given to all the patients in control group at baseline and at 1 month |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy Patients with age group 30-50 years diagnosed with (Stage I-III) periodontitis.
Key exclusion criteria (5 listed)
- Systemic diseases that may affect periodontal disease progression or outcome of treatment
- Patients on long term antibiotics
- Pregnant and lactating women
- Female patients with history of menopause
- Current orthodontic treatment or planning to undergo orthodontic treatment during study
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 |
|---|---|---|
| Motivational InterviewingA single individual motivational interviewing session will be delivered to each patient at baseline and 1 month | Behavioural | Motivation Interviewing |
| Oral hygiene instructionsOral hygiene instructions will be provided to each patient at baseline and at 1 month. | Behavioural | Oral hygiene Instructions |
Primary outcome
The Dental Treatment Motivation Scale (DTMS)
Time frame: Baseline, 3 month, 6 month
The Dental Treatment Motivation Scale (DTMS)19 questionnaire will be used to measure each participant's level of motivation. . The scale has a total of 15 items, which assess intrinsic (seven questions) and extrinsic motivation (eight questions). Answers provided on a scale are from 1 to 5, where 1 = "strongly disagree" and 5 = "strongly agree." Patients will complete the questionnaire at the 3, 6 month follow-up appointment after periodontal treatment. Higher score indicates higher level of patient motivation towards dental treatment.
Patient related outcome Measure
Time frame: Baseline, 3 month, 6 month
The Oral Health Impact Profile-14 (OHIP-14) questionnaire will be used to measure each participant's Oral Health related quality of life (OHRQoL). It evaluates 14 questions under seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (1=never to 5=very often) with total scores ranging from 0-56 (higher scores indicate worse Oral health quality of life).
Evaluation of Patient's Self Efficacy
Time frame: Baseline, 3 month, 6 month
The Oral Hygiene Related Self Efficacy Scale (OHSE) questionnaire will be used for assessing self-efficacy. It includes 19 items rated on 4 point Likert scale from (1) Completely confident not to (4) Completely confident. Higher scores indicate stronger belief in one's ability to maintain oral health, correlating with better hygiene practices and treatment outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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.
Dr. Rajinder Kumar Sharma, MDS study director
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 Motivational Interviewing and Oral hygiene instructions in people with Motivational Interviewing 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akanksha Mahajan (+916284480549, akankshamahajan81198@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dental Treatment Motivation Scale (DTMS) (time frame: Baseline, 3 month, 6 month). 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 3 Jun 2026.