Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics
20. juni 2026 oppdatert av: Tehran University of Medical Sciences
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.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
72
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Tehran, Iran, 1439955991
- Faculty of Dentistry, Tehran University of Medical Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.
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Eksperimentell: 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.
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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.
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Eksperimentell: 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.
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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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Plaque Index (PI)
Tidsramme: Baseline and 4 weeks after intervention
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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.
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Baseline and 4 weeks after intervention
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2025
Primær fullføring (Faktiske)
27. september 2025
Studiet fullført (Faktiske)
8. april 2026
Datoer for studieregistrering
Først innsendt
23. desember 2025
Først innsendt som oppfylte QC-kriteriene
20. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juni 2026
Sist bekreftet
1. november 2024
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IR.TUMS.DENTISTRY.REC.1402.096
Plan for individuelle deltakerdata (IPD)
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