- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Homs, Syrien
- Al-Hawash Private University, Faculty of Dentistry
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Miswak Side
50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak.
|
|
|
Aktiv komparator: Manual Toothbrush Side
The contralateral randomized side of the jaw assigned to be cleaned using a conventional manual toothbrush.
|
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Quigley-Hein Plaque Index (mQH) Score
Tidsram: Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).
|
Mesial, distal, and mid surfaces of facial and lingual aspects were scored. Scoring was as follows: 0 = no plaque/debris
|
Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Ali Abu Sulaiman, Al-Hawash Private University
- Huvudutredare: Fida Kaseeh, Ph.D. in Oral Medicine, Al-Hawash Private University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-06-2025
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