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

NCT07667283 | Completed

• 1 other identifier: IR.TUMS.DENTISTRY.REC.1402.096
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks after intervention

Study Arms (3)

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.

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.

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.

Behavioral: Pamphlet-Based Oral Hygiene Instruction

Interventions

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.

Video-Based Oral Hygiene Instruction

Verbal Oral Hygiene Instruction BEHAVIORAL

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

Face-to-face Oral Hygiene Instruction

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

Pamphlet-based Oral Hygiene Instruction

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Faculty of Dentistry, Tehran University of Medical Sciences

Tehran, 1439955991, Iran

Location

MeSH Terms

Conditions

Dental Caries; Health Education

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: June 25, 2026
• Study Start: January 1, 2025
• Primary Completion: September 27, 2025
• Study Completion: April 8, 2026
• Last Updated: June 25, 2026

Record last verified: 2024-11

Locations

IR (1)