Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

20. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Verbal Oral Hygiene Instruction
Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Plaque Index (PI)
Tidsramme: 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.
Baseline and 4 weeks after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tehran University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2025

Primær færdiggørelse (Faktiske)

27. september 2025

Studieafslutning (Faktiske)

8. april 2026

Datoer for studieregistrering

Først indsendt

23. december 2025

Først indsendt, der opfyldte QC-kriterier

20. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2026

Sidst verificeret

1. november 2024

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IR.TUMS.DENTISTRY.REC.1402.096

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Caries i tænderne

Kliniske forsøg med Verbal Oral Hygiene Instruction

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kuwait

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner