GingivitisMI-OrthoNCT07164989
Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients
A study testing Motivational Interviewing-Based Counseling and Standard Oral Health Education in people with Gingivitis and DMFT Index, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is being conducted to explore how motivational interviewing (MI), A patient-centered counseling method, can help improve oral health awareness and practices in adolescents undergoing orthodontic treatment. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, DMFT Index, Dental Plaque Index
- What is being tested?
- Motivational Interviewing-Based Counseling and Standard Oral Health Education
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 31 Jul 2026
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents aged 14-19 years
- Currently undergoing fixed orthodontic treatment with active appliances in the mouth
- Available for three study encounters over a 6-month period
- Able to read, understand, and communicate in English without the use of a translator
- Able to provide consent, and whose parent/guardian also agrees to provide consent
Who cannot join
- Patients with systemic diseases or conditions that may impact oral health
- Patients who are expected to complete orthodontic treatment or have appliances removed within 6 months
- Individuals requiring interpreter services for participation
- Individuals unable or unwilling to provide consent (or whose guardians cannot provide consent)
- Currently enrolled in another behavioral or oral health intervention study.
- Any condition deemed by the investigators to make the participant ineligible for safe and effective participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB School of Dentistry/ Department of Pediatric Dentistry
Birmingham, Alabama, 35233
About this study
Official title: A Patient-Centered Approach to Promote Oral Health Awareness and Practices Regarding Oral Hygiene in Adolescent Orthodontic Patients: A Randomized Controlled Trial Using Motivational Interviewing
This study is being conducted to explore how motivational interviewing (MI), A patient-centered counseling method, can help improve oral health awareness and practices in adolescents undergoing orthodontic treatment. Adolescents often struggle to maintain good oral hygiene during orthodontic care, which can lead to complications such as gum disease, tooth decay, and poor treatment outcomes.
Participants in this study will receive brief, structured conversations focused on encouraging them to set goals and take responsibility for their oral health. These interviews are designed to be non-judgmental and supportive, helping the participants explore their own motivations for keeping their teeth and gums healthy during braces treatment.
The study will take place at a pediatric dentistry clinic and will involve adolescents aged approximately 14 to 19 who are receiving orthodontic care. The goal is to assess whether this type of communication improves their oral hygiene behaviors and outcomes compared to standard oral health education. Findings from this research may help pediatric dentists and orthodontists improve how they engage adolescent patients in taking care of their oral health.
Read the detailed description
This study aims to assess the effectiveness of motivational interviewing (MI) in promoting oral health behaviors and awareness among adolescent orthodontic patients in a pediatric dentistry setting. Adolescents often face unique challenges in maintaining good oral hygiene during orthodontic treatment due to age-related factors such as motivation, compliance, and shifting priorities. As a result, they are at increased risk for plaque accumulation, gingival inflammation, and white spot lesions.
Motivational interviewing is a well-established, evidence-based counseling approach that focuses on enhancing an individual's intrinsic motivation to change by exploring and resolving ambivalence. It has shown promise in areas such as smoking cessation, weight management, and medication adherence, but its application in oral health-especially among adolescents-remains underutilized.
This randomized controlled trial will enroll adolescent patients between the ages of 14 and 19 who are currently undergoing fixed orthodontic treatment. Participants will be randomly assigned to either the intervention group (receiving MI-based counseling sessions at routine orthodontic appointments) or the control group (receiving standard oral health education). The MI sessions will be brief (approximately 15-20 minutes), conducted by trained pediatric dental professionals, using a structured MI script and checklist based on established MI protocols.
The study will evaluate oral health behaviors through self-reported questionnaires and objective clinical measures, including plaque index, gingival index, and oral hygiene compliance as recorded in follow-up appointments. Secondary outcomes will include participant satisfaction, perceived autonomy in health decisions, and parental involvement in oral care.
Ethical safeguards include patient consent, parental consent, and measures to protect participant confidentiality. Given the low-risk, behavioral nature of the intervention, the study does not require a Data Monitoring Committee. All data will be monitored by the Principal Investigator and reviewed periodically by the study team to ensure fidelity and safety.
The findings from this study are expected to provide valuable insights into how motivational interviewing can be implemented effectively in clinical dental settings to improve adolescent engagement and long-term oral health outcomes.
- Conditions
- Gingivitis, DMFT Index, Dental Plaque Index, Oral Hygiene Education Methods, Oral Hygiene Reinforcement During Fixed Orthodontic Treatment, Motivational Interview, OHI
- Being tested
- Motivational Interviewing-Based Counseling, Standard Oral Health Education
- Keywords
- Motivational Interview, Oral Hygiene, Fixed Orthodontic Treatment
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing-Based CounselingBehavioural
Motivational interviewing (MI) is a structured, patient-centered counseling technique that helps individuals explore and resolve ambivalence toward behavior change. In this study, MI sessions will be delivered by trained pediatric dental professionals during routine orthodontic visits. Each session will last approximately 10-15 minutes and will be guided by a standardized MI protocol, focusing on improving oral hygiene behavior and increasing personal motivation and responsibility for oral care among adolescent participants. Sessions will be conducted at multiple time points during the course of treatment.
Standard Oral Health EducationBehavioural
Participants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Group | Experimental | Motivational Interviewing (MI) will be conducted as the primary behavioral intervention in the study group. MI is a collaborative, patient-centered communication technique designed to enhance a patient's intrinsic motivation to adopt healthier behaviors. It involves five core processes: engaging, focusing, evoking, planning, and reviewing. These sessions aim to help patients identify their own goals and motivations related to oral hygiene and to foster a sense of autonomy and accountability.
In this study, MI sessions will be delivered by a single trained dental professional who has previous formal training and experience conducting MI as part of earlier research. To maintain quality and consistency, a structured MI script and checklist based on established MI protocols will be used for each session. Sessions will take place at three different time points throughout the study period. Receives: Behavioral: Motivational Interviewing-Based Counseling |
| Standard Oral Health Education Group | Experimental | Participants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI. Receives: Behavioral: Standard Oral Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Oral Hygiene as Measured by change in Plaque Index (Silness and Löe, 1964)
Description: Change in Plaque Index score from baseline to the 6-month follow-up. The Plaque Index is scored on a 0-3 scale, where 0 = no plaque, 1 = thin plaque detectable by probe or disclosing solution, 2 = moderate visible plaque, and 3 = abundant plaque. A decrease in score indicates improved oral hygiene.
Time Frame: Up to 6 months per participant Unit of Measure: Mean Plaque Index score (0-3 scale)
Measured: Up to 6 months per participant
Improvement in Oral Hygiene as Measured by change in Gingival Index (Silness and Löe, 1964)
Description: Change in Gingival Index score from baseline to the 6-month follow-up. The Gingival Index is scored on a 0-3 scale, where 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, and 3 = severe inflammation. A decrease in score indicates improved gingival health.
Time Frame: Up to 6 months per participant Unit of Measure: Mean Gingival Index score (0-3 scale)
Measured: Up to 6 months per participant
Change in Decayed, Missing, and Filled Teeth Index (DMFT)
Description:
The DMFT Index (Decayed, Missing, and Filled Teeth) is a standardized WHO measure of lifetime dental caries experience in permanent dentition. Each participant's teeth will be examined, and the number of decayed (D), missing (M, due to caries), and filled (F) teeth will be recorded. The total DMFT score is the sum of these categories, ranging from 0 (no caries experience) to 28 (all permanent teeth affected). Lower scores represent better oral health. Changes in DMFT from baseline to the 6-month follow-up will be assessed to determine the effectiveness of motivational interviewing compared to standard oral hygiene education.
Measured: Up to 6 months per participant
Secondary outcomes (1)
Self-Reported Oral Hygiene Behavior Questionnaire Score
Participants will complete a validated self-report questionnaire assessing their frequency and quality of oral hygiene practices (e.g., tooth brushing, flossing, use of interdental aids). Responses will be collected at baseline and at study completion. Improvement in self-reported oral hygiene behavior is expected in the motivational interviewing group compared to the control group. Self-Reported Oral Hygiene Behavior Questionnaire Score. Participants will complete a validated self-report questionnaire at baseline, 1 month, and 6 months. This will assess frequency and quality of oral hygiene practices (e.g., tooth brushing, flossing, use of interdental aids). Scoring: The questionnaire uses a Likert-type scale, with responses scored from 0 (least favorable behavior) to 4 (most favorable behavior). Range: Minimum = 0, Maximum = 20 (total score, depending on items used).
Higher scores indicate better oral hygiene behavior.
Measured: Up to 6 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start28 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Model description
- Participants will be randomized into two parallel arms: one receiving motivational interviewing-based counseling sessions, and one receiving standard oral health education during orthodontic care. The intervention will occur during routine follow-up visits.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Yin Lin, University of Alabama at Birmingham
- Investigators
- Yu Yin Lin, DDS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164989
- Sponsor's protocol ID
- 300014350
- Other IDs
- UAB
- Acronym
- MI-Ortho
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this study involves adolescent participants and collects identifiable behavioral and dental health data, individual participant data (IPD) will not be shared to protect participant confidentiality. However, aggregate results from the study will be published and shared through peer-reviewed journals and presentations.
Publications
Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
PubMed 30198774Cascaes AM, Bielemann RM, Clark VL, Barros AJ. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014 Feb;48(1):142-53. doi: 10.1590/s0034-8910.2014048004616.
PubMed 24789647
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Approach to Promote Oral Health Awareness and Practices Regarding Oral Hygiene in Adolescent Orthodontic Patients: A Randomized Controlled Trial Using Motivational Interviewing
- ClinicalTrials.gov ID
- NCT07164989
- Acronym / sponsor ID
- MI-Ortho / 300014350
- Conditions
- Gingivitis, DMFT Index, Dental Plaque Index, Oral Hygiene Education Methods, Oral Hygiene Reinforcement During Fixed Orthodontic Treatment, Motivational Interview, OHI
- Keywords
- Motivational Interview, Oral Hygiene, Fixed Orthodontic Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Sep 2025 (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.
This study is being conducted to explore how motivational interviewing (MI), A patient-centered counseling method, can help improve oral health awareness and practices in adolescents undergoing orthodontic treatment. Adolescents often struggle to maintain good oral hygiene during orthodontic care, which can lead to complications such as gum disease, tooth decay, and poor treatment outcomes.
Participants in this study will receive brief, structured conversations focused on encouraging them to set goals and take responsibility for their oral health. These interviews are designed to be non-judgmental and supportive, helping the participants explore their own motivations for keeping their teeth and gums healthy during braces treatment.
The study will take place at a pediatric dentistry clinic and will involve adolescents aged approximately 14 to 19 who are receiving orthodontic care. The goal is to assess whether this type of communication improves their oral hygiene behaviors and outcomes compared to standard oral health education. Findings from this research may help pediatric dentists and orthodontists improve how they engage adolescent patients in taking care of their oral health.
Detailed description
This study aims to assess the effectiveness of motivational interviewing (MI) in promoting oral health behaviors and awareness among adolescent orthodontic patients in a pediatric dentistry setting. Adolescents often face unique challenges in maintaining good oral hygiene during orthodontic treatment due to age-related factors such as motivation, compliance, and shifting priorities. As a result, they are at increased risk for plaque accumulation, gingival inflammation, and white spot lesions.
Motivational interviewing is a well-established, evidence-based counseling approach that focuses on enhancing an individual's intrinsic motivation to change by exploring and resolving ambivalence. It has shown promise in areas such as smoking cessation, weight management, and medication adherence, but its application in oral health-especially among adolescents-remains underutilized.
This randomized controlled trial will enroll adolescent patients between the ages of 14 and 19 who are currently undergoing fixed orthodontic treatment. Participants will be randomly assigned to either the intervention group (receiving MI-based counseling sessions at routine orthodontic appointments) or the control group (receiving standard oral health education). The MI sessions will be brief (approximately 15-20 minutes), conducted by trained pediatric dental professionals, using a structured MI script and checklist based on established MI protocols.
The study will evaluate oral health behaviors through self-reported questionnaires and objective clinical measures, including plaque index, gingival index, and oral hygiene compliance as recorded in follow-up appointments. Secondary outcomes will include participant satisfaction, perceived autonomy in health decisions, and parental involvement in oral care.
Ethical safeguards include patient consent, parental consent, and measures to protect participant confidentiality. Given the low-risk, behavioral nature of the intervention, the study does not require a Data Monitoring Committee. All data will be monitored by the Principal Investigator and reviewed periodically by the study team to ensure fidelity and safety.
The findings from this study are expected to provide valuable insights into how motivational interviewing can be implemented effectively in clinical dental settings to improve adolescent engagement and long-term oral health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel arms: one receiving motivational interviewing-based counseling sessions, and one receiving standard oral health education during orthodontic care. The intervention will occur during routine follow-up visits.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Group | Experimental | Behavioral: Motivational Interviewing-Based CounselingMotivational Interviewing (MI) will be conducted as the primary behavioral intervention in the study group. MI is a collaborative, patient-centered communication technique designed to enhance a patient's intrinsic motivation to adopt healthier behaviors. It involves five core processes: engaging, focusing, evoking, planning, and reviewing. These sessions aim to help patients identify their own goals and motivations related to oral hygiene and to foster a sense of autonomy and accountability. In this study, MI sessions will be delivered by a single trained dental professional who has previous formal training and experience conducting MI as part of earlier research. To maintain quality and consistency, a structured MI script and checklist based on established MI protocols will be used for each session. Sessions will take place at three different time points throughout the study period. |
| Standard Oral Health Education Group | Experimental | Behavioral: Standard Oral Health EducationParticipants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents aged 14-19 years
- Currently undergoing fixed orthodontic treatment with active appliances in the mouth
- Available for three study encounters over a 6-month period
- Able to read, understand, and communicate in English without the use of a translator
- Able to provide consent, and whose parent/guardian also agrees to provide consent
Key exclusion criteria (6 listed)
- Patients with systemic diseases or conditions that may impact oral health
- Patients who are expected to complete orthodontic treatment or have appliances removed within 6 months
- Individuals requiring interpreter services for participation
- Individuals unable or unwilling to provide consent (or whose guardians cannot provide consent)
- Currently enrolled in another behavioral or oral health intervention 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 Interviewing-Based CounselingMotivational interviewing (MI) is a structured, patient-centered counseling technique that helps individuals explore and resolve ambivalence toward behavior change. In this study, MI sessions will be delivered by trained pediatric dental professionals during routine orthodontic visits. Each session will last approximately 10-15 minutes and will be guided by a standardized MI protocol, focusing on improving oral hygiene behavior and increasing personal motivation and responsibility for oral care among adolescent participants. Sessions will be conducted at multiple time points during the course of treatment. | Behavioural | Motivational Interviewing Group |
| Standard Oral Health EducationParticipants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI. | Behavioural | Standard Oral Health Education Group |
Primary outcome
Improvement in Oral Hygiene as Measured by change in Plaque Index (Silness and Löe, 1964)
Time frame: Up to 6 months per participant
Description: Change in Plaque Index score from baseline to the 6-month follow-up. The Plaque Index is scored on a 0-3 scale, where 0 = no plaque, 1 = thin plaque detectable by probe or disclosing solution, 2 = moderate visible plaque, and 3 = abundant plaque. A decrease in score indicates improved oral hygiene. Time Frame: Up to 6 months per participant Unit of Measure: Mean Plaque Index score (0-3 scale)
Improvement in Oral Hygiene as Measured by change in Gingival Index (Silness and Löe, 1964)
Time frame: Up to 6 months per participant
Description: Change in Gingival Index score from baseline to the 6-month follow-up. The Gingival Index is scored on a 0-3 scale, where 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, and 3 = severe inflammation. A decrease in score indicates improved gingival health. Time Frame: Up to 6 months per participant Unit of Measure: Mean Gingival Index score (0-3 scale)
Change in Decayed, Missing, and Filled Teeth Index (DMFT)
Time frame: Up to 6 months per participant
Description: The DMFT Index (Decayed, Missing, and Filled Teeth) is a standardized WHO measure of lifetime dental caries experience in permanent dentition. Each participant's teeth will be examined, and the number of decayed (D), missing (M, due to caries), and filled (F) teeth will be recorded. The total DMFT score is the sum of these categories, ranging from 0 (no caries experience) to 28 (all permanent teeth affected). Lower scores represent better oral health. Changes in DMFT from baseline to the 6-month follow-up will be assessed to determine the effectiveness of motivational interviewing compared to standard oral hygiene education.
1 secondary outcome
Self-Reported Oral Hygiene Behavior Questionnaire Score
Time frame: Up to 6 months per participant
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 Feb 2026.
- Background: PubMed 30198774Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
- Background: PubMed 24789647Cascaes AM, Bielemann RM, Clark VL, Barros AJ. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014 Feb;48(1):142-53. doi: 10.1590/s0034-8910.2014048004616.
- Motivational interviewing workbook for dental professionals, provides guidance for behavior change strategies in oral health care.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Because this study involves adolescent participants and collects identifiable behavioral and dental health data, individual participant data (IPD) will not be shared to protect participant confidentiality. However, aggregate results from the study will be published and shared through peer-reviewed journals and presentations.
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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.
Yu Yin Lin, DDS principal investigator
University of Alabama at Birmingham
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-Based Counseling and Standard Oral Health Education in people with Gingivitis and DMFT Index, run by University of Alabama at Birmingham at 1 site in United States.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 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 United States. 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?
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?
Improvement in Oral Hygiene as Measured by change in Plaque Index (Silness and Löe, 1964) (time frame: Up to 6 months per participant). 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?
On the ClinicalTrials.gov record for NCT07164989, which also lists 2 linked publications.
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 Feb 2026.