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Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07667283
Enrollment
72
Registered
2026-06-25
Start date
2025-01-01
Completion date
2026-04-08
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding on Probing, Dental Caries, Gingival Index, Plaque Index

Keywords

Bleeding On Probing, Oral Hygiene Index, Gingival Index, Fixed Orthodontics, Health Education, Caries index

Brief 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. 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.

Interventions

Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.

BEHAVIORALPamphlet-Based Oral Hygiene Instruction

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

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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients with fixed orthodontics aged 12 to 18 years 2. Patient cooperation to participate in the study and follow-up 3. Patients with no history of systemic and mental illnesses and no use of neuropsychiatric medications 4. Patients who are not participating in another study related to oral health 5. Patients who do not have caries or periodontal problems at the beginning of orthodontic treatment (GI, PI, and BOP indices are less than 10%) 6. Patients whose brackets have been placed by an orthodontist (specialized department and special clinic) and under the bonding principles mentioned in the text books.

Exclusion criteria

1. Patients who are not cooperative. 2. Patients with systemic diseases and cleft palate and syndromes affecting the study results and health indicators. 3. Patients with caries or periodontal problems with significant Clinical Attachment Loss (GI, PI and BOP indices are more than 10%) 4. Patients using medications that affect plaque adhesion, such as mouthwashes 5. Patients with a history of long-term antibiotic use 6. Smokers 7. Patients with dental anomalies 8. Patients with mental and physical problems that prevent oral hygiene 9. Patients with dental impaction 10. Patients with a treatment plan that includes extraoral appliances

Design outcomes

Primary

MeasureTime frameDescription
Change in Plaque Index (PI)Baseline and 4 weeks after interventionThe 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026