Periodontitis With Low Oral Hygiene-related Self-efficacyNCT07614737
Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes
A study testing Behavioural intervention and Conventional oral hygiene instructions in people with Periodontitis With Low Oral Hygiene-related Self-efficacy, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Periodontitis is a chronic inflammatory disease in which long-term treatment success depends greatly on patients' adherence to oral hygiene practices and periodontal therapy. Psychological factors such as oral hygiene-related self-efficacy and illness perception may influence patients' motivation and ability to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis With Low Oral Hygiene-related Self-efficacy
- What is being tested?
- Behavioural intervention and Conventional 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
- 78 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2026to 30 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria at the patient level, age ≥ 18 years
- According to the 2017 EFP/AAP classification, patients with periodontitis stage I-III, with low self-efficacy will be included
- According to American Society of Anaesthesiologists Physical Status classification P1 and P2 will be included.
Who cannot join
- Patients will be excluded from the study if they have any of the following characteristics
- According to American Society of Anesthesiologists Physical Status classification P3 and P4 will be excluded.
- Use of antibiotics within 6 months prior to the study
- Xerostomia
- Physical inability to perform oral hygiene procedures
- Use of drugs influencing gingival hyperplasia or bleeding.
- Presence of an acute condition requiring emergency dental treatment
- Any periodontal treatment in the past 1 year
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
Postgraduate institute of dental sciences
Rohtak, Haryana, 124001
Dr. Ritika Arora, +917027818084, drritika44@gmail.com
About this study
Official title: "Evaluation of an Individual-centric Self-efficacy Based Behavioural Intervention on Adherence and Clinical Outcomes of Periodontal Therapy-A Randomised Controlled Trial"
Periodontitis is a chronic inflammatory disease in which long-term treatment success depends greatly on patients' adherence to oral hygiene practices and periodontal therapy. Psychological factors such as oral hygiene-related self-efficacy and illness perception may influence patients' motivation and ability to maintain effective plaque control and attend follow-up visits. However, limited evidence exists regarding the impact of behavioural interventions on adherence and clinical outcomes in periodontal therapy.
This randomized controlled trial aims to evaluate the effect of an behavioural intervention on treatment adherence and clinical periodontal outcomes in patients with Stage I-III periodontitis having low oral hygiene-related self-efficacy. A total of 78 participants will be randomized into test and control groups. Both groups will receive Step 1 and 2 periodontal therapy, including professional mechanical plaque removal and risk factor control. The test group will additionally receive a self-efficacy-based behavioural intervention while the control group will receive conventional oral hygiene instructions.
Clinical periodontal parameters including Turesky modification of Quigley-Hein Plaque Index (TQHI), Full Mouth Bleeding Score (FMBS), probing pocket depth (PPD), and clinical attachment level (CAL) will be assessed at baseline, 8 weeks, and 6 months. Oral hygiene self-efficacy and illness perception will also be evaluated using validated questionnaires. The primary outcomes will be treatment adherence and treatment response at 6 months. The study aims to determine whether a self-efficacy-based behavioural approach can improve adherence and enhance periodontal treatment outcomes.
- Being tested
- Behavioural intervention, Conventional oral hygiene instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural interventionBehavioural
Behavioural intervention based on Bandura's self-efficacy theory aimed at improving oral hygiene adherence and periodontal treatment outcomes through patient motivation and reinforcement strategies.
Conventional oral hygiene instructionsBehavioural
Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Participants will receive Step 1 and 2 periodontal therapy along with an individual-centric self-efficacy-based behavioural intervention including verbal persuasion, mastery experience, vicarious experience, and emotional reinforcement in addition to conventional oral hygiene instructions. Receives: Behavioral: Behavioural intervention |
| Control Group | Active comparator | Participants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions. Receives: Behavioral: Conventional oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
TREATMENT ADHERENCE SCORE
Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended
Measured: 6 months
Secondary outcomes (7)
PLAQUE INDEX
Turesky modification of Quigley-Hein Index (TQHI) Will be used to assess plaque score. Score range is 0 to 5. Lesser Score means better outcome and higher score means worst outcome
Measured: 6 months
Full mouth bleeding score (FMBS)
FMBS is expressed as a percentage of bleeding sites:
FMBS (%) = (Bleeding sites/Total sites)*100
0% → No bleeding (excellent gingival health) 100% → Bleeding at all sites (severe inflammation)
Measured: 6 months
PERCENTAGE RESIDUAL POCKETS
Treatment response- defined as the percentage sites with residual probing depth less than or equal to 4 mm without bleeding on probing at 6 months
Measured: 6 months
Pocket Probing Depth
Measured: 6 months
Clinical Attachment level
Measured: 6 months
Changes in oral hygiene related self efficacy score
Score ranges from 19 to 76.lesser score means low self efficacy and higher score means high self efficacy related to oral hygiene.
Measured: 6 months
Changes in brief Illness perception questionnaire score
Score ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.
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 posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis With Low Oral Hygiene-related Self-efficacyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614737
- Sponsor's protocol ID
- Ankit Kumar
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of an Individual-centric Self-efficacy Based Behavioural Intervention on Adherence and Clinical Outcomes of Periodontal Therapy-A Randomised Controlled Trial"
- ClinicalTrials.gov ID
- NCT07614737
- Acronym / sponsor ID
- Ankit Kumar
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 May 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.
Periodontitis is a chronic inflammatory disease in which long-term treatment success depends greatly on patients' adherence to oral hygiene practices and periodontal therapy. Psychological factors such as oral hygiene-related self-efficacy and illness perception may influence patients' motivation and ability to maintain effective plaque control and attend follow-up visits. However, limited evidence exists regarding the impact of behavioural interventions on adherence and clinical outcomes in periodontal therapy.
This randomized controlled trial aims to evaluate the effect of an behavioural intervention on treatment adherence and clinical periodontal outcomes in patients with Stage I-III periodontitis having low oral hygiene-related self-efficacy. A total of 78 participants will be randomized into test and control groups. Both groups will receive Step 1 and 2 periodontal therapy, including professional mechanical plaque removal and risk factor control. The test group will additionally receive a self-efficacy-based behavioural intervention while the control group will receive conventional oral hygiene instructions.
Clinical periodontal parameters including Turesky modification of Quigley-Hein Plaque Index (TQHI), Full Mouth Bleeding Score (FMBS), probing pocket depth (PPD), and clinical attachment level (CAL) will be assessed at baseline, 8 weeks, and 6 months. Oral hygiene self-efficacy and illness perception will also be evaluated using validated questionnaires. The primary outcomes will be treatment adherence and treatment response at 6 months. The study aims to determine whether a self-efficacy-based behavioural approach can improve adherence and enhance periodontal treatment outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Behavioral: Behavioural interventionParticipants will receive Step 1 and 2 periodontal therapy along with an individual-centric self-efficacy-based behavioural intervention including verbal persuasion, mastery experience, vicarious experience, and emotional reinforcement in addition to conventional oral hygiene instructions. |
| Control Group | Active comparator | Behavioral: Conventional oral hygiene instructionsParticipants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions. |
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, age ≥ 18 years
- According to the 2017 EFP/AAP classification, patients with periodontitis stage I-III, with low self-efficacy will be included
- According to American Society of Anaesthesiologists Physical Status classification P1 and P2 will be included.
Key exclusion criteria (8 listed)
- Patients will be excluded from the study if they have any of the following characteristics
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 |
|---|---|---|
| Behavioural interventionBehavioural intervention based on Bandura's self-efficacy theory aimed at improving oral hygiene adherence and periodontal treatment outcomes through patient motivation and reinforcement strategies. | Behavioural | Test Group |
| Conventional oral hygiene instructionsRoutine oral hygiene education and instructions provided during non-surgical periodontal therapy. | Behavioural | Control Group |
Primary outcome
TREATMENT ADHERENCE SCORE
Time frame: 6 months
Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended
7 secondary outcomes
PLAQUE INDEX
Time frame: 6 months
Full mouth bleeding score (FMBS)
Time frame: 6 months
PERCENTAGE RESIDUAL POCKETS
Time frame: 6 months
Pocket Probing Depth
Time frame: 6 months
Clinical Attachment level
Time frame: 6 months
Changes in oral hygiene related self efficacy score
Time frame: 6 months
Changes in brief Illness perception questionnaire score
Time frame: 6 months
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 29 May 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural intervention and Conventional oral hygiene instructions in people with Periodontitis With Low Oral Hygiene-related Self-efficacy, 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 8 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 29 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?
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 Ankit Kumar (+917027808084, ankit7027808084@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TREATMENT ADHERENCE SCORE (time frame: 6 months). 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 29 May 2026.