Completed

NCT Number: NCT07667283

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

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.

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Key information

Conditions

Dental Caries Adherence Interventions Behavior Bleeding on Probing Gingival Index Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Plaque Index Stomatognathic Diseases Tooth Demineralization Tooth Diseases Treatment Adherence and Compliance

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tehran University of Medical Sciences

Tehran, 1439955991, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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
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

Treatment and study plan

Verbal Oral Hygiene Instruction

Behavioral

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

Pamphlet-Based Oral Hygiene Instruction

Behavioral

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 instruction

Behavioral

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jun 25, 2026
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed