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

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 Overview

• Status: Completed
• Conditions: Dental Caries; Gingival Index; Bleeding on Probing; Plaque Index
• Intervention / Treatment: Behavioral: Verbal Oral Hygiene Instruction; Behavioral: Video-Based Oral Hygiene Instruction; Behavioral: Pamphlet-Based Oral Hygiene Instruction

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Tehran, Iran, 1439955991
    • Faculty of Dentistry, Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face-to-face Oral Hygiene Instruction; 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; Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.
Experimental: Video-Based Oral Hygiene Instruction; 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; 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.
Experimental: Pamphlet-based Oral Hygiene Instruction; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): September 27, 2025
• Study Completion (Actual): April 8, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: June 20, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 20, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Bleeding On Probing, Oral Hygiene Index, Gingival Index, Fixed Orthodontics, Health Education, Caries index
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Dental Caries; Health Education
• Other Study ID Numbers: IR.TUMS.DENTISTRY.REC.1402.096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No