Dental CariesNCT07667283
Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics
A study testing Verbal Oral Hygiene Instruction, Pamphlet-Based Oral Hygiene Instruction and Video-Based Oral Hygiene Instruction in people with Dental Caries and Bleeding on Probing, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Bleeding on Probing, Gingival Index
- What is being tested?
- Verbal Oral Hygiene Instruction, Pamphlet-Based Oral Hygiene Instruction and Video-Based Oral Hygiene Instruction
- 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
- 72 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2025to 8 Apr 2026
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with fixed orthodontics aged 12 to 18 years
- Patient cooperation to participate in the study and follow-up
- Patients with no history of systemic and mental illnesses and no use of neuropsychiatric medications
- Patients who are not participating in another study related to oral health
- Patients who do not have caries or periodontal problems at the beginning of orthodontic treatment (GI, PI, and BOP indices are less than 10%)
- Patients whose brackets have been placed by an orthodontist (specialized department and special clinic) and under the bonding principles mentioned in the text books.
Who cannot join
- Patients who are not cooperative.
- Patients with systemic diseases and cleft palate and syndromes affecting the study results and health indicators.
- Patients with caries or periodontal problems with significant Clinical Attachment Loss (GI, PI and BOP indices are more than 10%)
- Patients using medications that affect plaque adhesion, such as mouthwashes
- Patients with a history of long-term antibiotic use
- Smokers
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- Patients with dental anomalies
- Patients with mental and physical problems that prevent oral hygiene
- Patients with dental impaction
- Patients with a treatment plan that includes extraoral appliances
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Dentistry, Tehran University of Medical Sciences
Tehran, 1439955991
About this study
Official title: Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics Referring to the Orthodontic Department and Clinic of Tehran University of Medical Sciences, A Randomized Clinical Trial
The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. The main questions it aims to answer are:
Which method of oral hygiene instruction-video-based, written, or face-to-face education-is most effective in improving oral health?
Read more
Do these education methods help lower dental plaque and gum inflammation during orthodontic treatment?
Researchers will compare the three groups of participants who receive different types of oral hygiene training to see which method leads to the best oral health results.
Participants will:
Receive one of three types of oral hygiene instruction (video, written, or in-person).
Continue their regular orthodontic care and brushing routine.
Have their oral health checked at different times during the study to measure changes in plaque and gum health.
The study hopes to identify the most effective and practical way to teach young orthodontic patients to keep their teeth and gums healthy while wearing braces.
- Conditions
- Dental Caries, Bleeding on Probing, Gingival Index, Plaque Index
- Being tested
- Verbal Oral Hygiene Instruction, Pamphlet-Based Oral Hygiene Instruction, Video-Based Oral Hygiene Instruction
- Keywords
- Bleeding On Probing, Oral Hygiene Index, Gingival Index, Fixed Orthodontics, Health Education, Caries index
- Medical subject headings
- Dental Caries, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal Oral Hygiene InstructionBehavioural
Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.
Pamphlet-Based Oral Hygiene InstructionBehavioural
Participants receive a standardized printed pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, fluoride toothpaste use, and maintenance of fixed orthodontic appliances
Video-Based Oral Hygiene InstructionBehavioural
Participants view a standardized educational video demonstrating proper toothbrushing, interdental cleaning, and care for fixed orthodontic appliances. The video includes animations and real-life demonstrations to ensure consistent delivery of information.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Oral Hygiene Instruction | Experimental | Participants receive traditional chairside oral hygiene instruction delivered verbally by a trained dentist or oral health educator. Instructions include proper toothbrushing technique, use of fluoride toothpaste, interdental cleaning, and care of orthodontic appliances. Receives: Behavioral: Verbal Oral Hygiene Instruction |
| Video-Based Oral Hygiene Instruction | Experimental | Participants receive oral hygiene instruction using a video and visual demonstration on toothbrushing, interdental cleaning, and care of orthodontic appliances. Receives: Behavioral: Video-Based Oral Hygiene Instruction |
| Pamphlet-based Oral Hygiene Instruction | Experimental | Participants receive oral hygiene instruction through a printed educational pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, use of fluoride toothpaste, and care of orthodontic appliances. Receives: Behavioral: Pamphlet-Based Oral Hygiene Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI)
The Plaque Index (PI) will be measured using the Silness and Löe method to assess the level of dental plaque accumulation. The outcome represents the change in PI scores from baseline to 4-week follow-up among participants in the three intervention groups (verbal, pamphlet, video). Lower scores indicate improved oral hygiene status. The measure evaluates the effectiveness of each instructional method in reducing plaque accumulation in adolescents with fixed orthodontic appliances.
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2025
- Primary completion27 Sep 2025
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667283
- Sponsor's protocol ID
- IR.TUMS.DENTISTRY.REC.1402.096
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics Referring to the Orthodontic Department and Clinic of Tehran University of Medical Sciences, A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07667283
- Acronym / sponsor ID
- IR.TUMS.DENTISTRY.REC.1402.096
- Conditions
- Dental Caries, Bleeding on Probing, Gingival Index, Plaque Index
- Keywords
- Bleeding On Probing, Oral Hygiene Index, Gingival Index, Fixed Orthodontics, Health Education, Caries index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 25 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.
The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. The main questions it aims to answer are:
Which method of oral hygiene instruction-video-based, written, or face-to-face education-is most effective in improving oral health?
Do these education methods help lower dental plaque and gum inflammation during orthodontic treatment?
Researchers will compare the three groups of participants who receive different types of oral hygiene training to see which method leads to the best oral health results.
Participants will:
Receive one of three types of oral hygiene instruction (video, written, or in-person).
Continue their regular orthodontic care and brushing routine.
Have their oral health checked at different times during the study to measure changes in plaque and gum health.
The study hopes to identify the most effective and practical way to teach young orthodontic patients to keep their teeth and gums healthy while wearing braces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Oral Hygiene Instruction | Experimental | Behavioral: Verbal Oral Hygiene InstructionParticipants receive traditional chairside oral hygiene instruction delivered verbally by a trained dentist or oral health educator. Instructions include proper toothbrushing technique, use of fluoride toothpaste, interdental cleaning, and care of orthodontic appliances. |
| Video-Based Oral Hygiene Instruction | Experimental | Behavioral: Video-Based Oral Hygiene InstructionParticipants receive oral hygiene instruction using a video and visual demonstration on toothbrushing, interdental cleaning, and care of orthodontic appliances. |
| Pamphlet-based Oral Hygiene Instruction | Experimental | Behavioral: Pamphlet-Based Oral Hygiene InstructionParticipants receive oral hygiene instruction through a printed educational pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, use of fluoride toothpaste, and care of orthodontic appliances. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with fixed orthodontics aged 12 to 18 years
- Patient cooperation to participate in the study and follow-up
- Patients with no history of systemic and mental illnesses and no use of neuropsychiatric medications
- Patients who are not participating in another study related to oral health
- Patients who do not have caries or periodontal problems at the beginning of orthodontic treatment (GI, PI, and BOP indices are less than 10%)
Key exclusion criteria (10 listed)
- Patients who are not cooperative.
- Patients with systemic diseases and cleft palate and syndromes affecting the study results and health indicators.
- Patients with caries or periodontal problems with significant Clinical Attachment Loss (GI, PI and BOP indices are more than 10%)
- Patients using medications that affect plaque adhesion, such as mouthwashes
- Patients with a history of long-term antibiotic use
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 |
|---|---|---|
| Verbal Oral Hygiene InstructionParticipants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline. | Behavioural | Face-to-face Oral Hygiene Instruction |
| Pamphlet-Based Oral Hygiene InstructionParticipants receive a standardized printed pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, fluoride toothpaste use, and maintenance of fixed orthodontic appliances | Behavioural | Pamphlet-based Oral Hygiene Instruction |
| Video-Based Oral Hygiene InstructionParticipants view a standardized educational video demonstrating proper toothbrushing, interdental cleaning, and care for fixed orthodontic appliances. The video includes animations and real-life demonstrations to ensure consistent delivery of information. | Behavioural | Video-Based Oral Hygiene Instruction |
Primary outcome
Change in Plaque Index (PI)
Time frame: Baseline and 4 weeks after intervention
The Plaque Index (PI) will be measured using the Silness and Löe method to assess the level of dental plaque accumulation. The outcome represents the change in PI scores from baseline to 4-week follow-up among participants in the three intervention groups (verbal, pamphlet, video). Lower scores indicate improved oral hygiene status. The measure evaluates the effectiveness of each instructional method in reducing plaque accumulation in adolescents with fixed orthodontic appliances.
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Oral Hygiene Instruction, Pamphlet-Based Oral Hygiene Instruction and Video-Based Oral Hygiene Instruction in people with Dental Caries and Bleeding on Probing, run by Tehran University of Medical Sciences at 1 site in Iran.
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 6 inclusion and 10 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 25 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 Iran. 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?
Change in Plaque Index (PI) (time frame: Baseline and 4 weeks after intervention). 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 25 Jun 2026.