- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07563400
Plaque Removal in Children Using Charcoal and Nylon Toothbrushes
27. april 2026 opdateret af: Mennatullah Yasser Sayed Abou El Enein, Cairo University
Efficacy of Plaque Removal and Antibacterial Properties of Charcoal Infused Bristle Vs Nylon Bristle Toothbrushes in Children: A Randomized Clinical Trial
This study will compare two types of toothbrushes in children: a charcoal-infused bristle toothbrush and a regular nylon bristle toothbrush.
We want to see which toothbrush is better at removing plaque and reducing bacteria in the mouth.
Children will be randomly assigned to use one of the toothbrushes.
We will measure the levels of bacteria in small samples of fluid taken from the gums to see if one toothbrush reduces harmful bacteria more than the other.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
This study is a clinical trial designed to compare the effectiveness of two types of toothbrushes in children aged 6-10.
One group of children will use a toothbrush with charcoal-infused bristles, while the other group will use a standard nylon bristle toothbrush.
All children will be taught the same brushing technique and will brush their teeth twice daily for two minutes using a pea-sized amount of toothpaste.The study will last two weeks.
Researchers will measure four times how much dental plaque is removed from each child's teeth, collect samples from the gums to examine bacteria, and test the toothbrush bristles for bacterial contamination by counting bacterial colonies.The goal is to determine which toothbrush is better at cleaning teeth and reducing harmful bacteria in the mouth.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mennatullah Y Abou El Enein
- Telefonnummer: +201111184215
- E-mail: mennatullah.yasser@dentistry.cu.edu.eg
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
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
● Children aged 6 to 10 years.
- Medically free patients with no physical disability.
- Patients must have proper oral hygiene.
- Cooperative patients who will comply with follow-ups.
- Parents who accept to sign informed consent.
Exclusion Criteria:
● Children with a medical condition or physical disability,
- Children undergoing antibiotic treatment
- Children with crowding, fixed or removable orthodontic appliances.
- Children with pre-shedding mobile teeth were excluded from study.
- Children who will be unable to attend follow-up visits.
- Parents refuse to give written formed consent.
- Presence of painful teeth.
- Presence of active carious lesions
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Charcoal-Infused Bristle Toothbrush
Children in this arm will use a soft charcoal-infused bristle toothbrush twice daily for two minutes each time, using a pea-sized amount of fluoride-free toothpaste (Dabur Herb'l, India).
Participants will be trained in the horizontal scrub technique and instructed on proper toothbrush storage to minimize bacterial contamination.
|
manual toothbrush with soft charcoal infused bristles designed fordaily oral hygiene measures.
Participants will be instructed to brush twice daily for two minutes using herbal toothpaste
|
|
Aktiv komparator: Nylon Bristle Toothbrush
Children in this arm will use a soft nylon bristle toothbrush twice daily for two minutes each time, using a pea-sized amount of fluoride-free toothpaste Participants will be trained in the horizontal scrub technique and instructed on proper toothbrush storage to minimize bacterial contamination.
|
Manual toothbrush with soft nylon bristles designed for daily oral hygiene measures.
Participants will be instructed to brush twice daily for two minutes using herbal toothpaste
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in full-mouth plaque score assessed by O'Leary Plaque Control Index from baseline to 2 weeks
Tidsramme: aseline, immediately after training, 1 week, and 2 weeks post-training
|
Full-mouth plaque score will be measured using the O'Leary Plaque Control Index at four time points: baseline (before training), immediately after training, one week, and two weeks post-training.
Each tooth surface (mesial, distal, buccal, and lingual) will be examined.
The plaque score will be expressed as the percentage of plaque-containing surfaces relative to the total number of surfaces examined
|
aseline, immediately after training, 1 week, and 2 weeks post-training
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juli 2026
Studieafslutning (Anslået)
1. august 2026
Datoer for studieregistrering
Først indsendt
27. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
4. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CU-PD-RCT-CHARCOAL-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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