- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07619014
Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients
Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients: A Randomized Split-Mouth Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The maintaining of excellent oral hygiene is a significant challenge for patients undergoing orthodontic treatment due to the presence of fixed brackets and archwires, which act as retentive areas for dental biofilm accumulation. While the conventional manual toothbrush is widely prescribed, the natural Miswak (Salvadora persica) serves as a popular traditional oral hygiene tool with documented mechanical and antimicrobial properties. However, there is a lack of split-mouth clinical trials directly evaluating and comparing their immediate mechanical efficacy in the presence of orthodontic appliances.
This study utilizes a split-mouth experimental design to minimize inter-individual variability, where each participant serves as their own control. The mouth of each patient is randomized to use the natural Miswak on one side and the conventional manual toothbrush on the contralateral side during a single clinical session with no subsequent follow-up.
Aim: To evaluate and compare the immediate efficacy of the natural Miswak versus a manual toothbrush (using the Modified Bass technique) in reducing dental plaque scores among a sample of patients with fixed orthodontic appliances at Al-Hawash Private University.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ali Abu Sulaiman, Ph.D. in Periodontology
- Telefonnummer: +963956790836
- E-mail: dr.ali.abousulaiman@hpu.edu.sy
Undersøgelse Kontakt Backup
- Navn: Fida Kaseeh, Ph.D. in Oral Medicine
- E-mail: fidakaseeh@hpu.edu.sy
Studiesteder
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Homs, Syrien
- Rekruttering
- Al-Hawash Private University, Faculty of Dentistry
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Kontakt:
- Ali Abu Sulaiman, Ph.D. in Periodontology
- Telefonnummer: +963956790836
- E-mail: dr.ali.abousulaiman@hpu.edu.sy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged between 18 and 30 years old.
- Presence of fixed orthodontic appliances (brackets and wires) on both upper and lower arches.
- Good general systemic health with the absence of any medical conditions that might affect oral health status.
Exclusion Criteria:
- Presence of advanced or aggressive periodontal diseases.
- Current smokers.
- Use of antimicrobial or antibacterial mouthwashes within 24 hours prior to the study session.
- Systemic antibiotic intake within the past 2 weeks preceding the experiment.
- Any physical or motor disability that could hinder the patient's capacity to perform proper tooth brushing.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Miswak Side
50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak.
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Aktiv komparator: Manual Toothbrush Side
The contralateral randomized side of the jaw assigned to be cleaned using a conventional manual toothbrush.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Quigley-Hein Plaque Index (mQH) Score
Tidsramme: Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).
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Mesial, distal, and mid surfaces of facial and lingual aspects were scored. Scoring was as follows: 0 = no plaque/debris
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Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Ali Abu Sulaiman, Al-Hawash Private University
- Ledende efterforsker: Fida Kaseeh, Ph.D. in Oral Medicine, Al-Hawash Private University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-06-2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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