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"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children

9. september 2022 oppdatert av: Zainab Jahanzeb, Dow University of Health Sciences

"Comparing the Plaque Removal Ability of Triple Head Tooth Brush Versus Single Head Tooth Brush Among School Based Cerebral Palsy Children:A Randomized Control Trial"

It was an intervention utilizing two toothbrushes on school going cerebral palsy children age (6 -18 yrs). The triple head tooth brush and single head brush was provided to parents along with dental health education to their parent on brushing technique and oral care for their child. Parents who give consent for their child were enrolled in the study. The plaque removal ability of toothbrush was assessed by Turesky modified Quigley Hein index. The reading for plaque score was recorded at base line and after the follow up of 4 weeks. Difficulties during brushing was also analyzed.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Study Design :Single blinded Randomized Control Trial

Study Setting: The study was conducted in schools that have cerebral palsy children in Karachi.

Study Duration :From June 2021 to June 2022.

Sampling technique: Non probability purposive sampling technique was used for selection of study population.

Sample Size: Total 58 individuals were recruited in the study. After including the 20% drop out rate 35 subjects were enrolled at each study group which make total sample size of 70 Cerebral Palsy participants. Random allocation was made in two groups in order to keep the sizes of intervention groups similar.

Study Instrument:

  • For study intervention two types of tooth brushes were used. The single head and triple head tooth brush.
  • For data collection a structured questionnaire was used that collect information on social demographic characteristics, oral hygiene behavior, dentition status, plaque status and difficulties associated with brushing.

Data Collection Method:

  • The study used a single-blind, parallel, and randomized controlled trial (RCT) design.
  • A total 70 Cerebral palsy children were recruited in the study which was stratified into two groups of 35 children each in intervention and control group.
  • Intervention group was given triple head tooth brush with fluoridated toothpaste whereas control group was given single head tooth brush with fluoridated toothpaste.
  • Dental health education on oral care was given to participant's parent along with brushing technique demonstrated on model as well on their child's teeth.
  • Data was collected through structured questionnaire. Oral health assessment was recorded through DMFT/dmft index. Plaque index was calculated by Turesky modified Quigley Hein index by dyeing the plaque on tooth surface by plaque disclosing tablets. Difficulties during brushing were also evaluated.
  • Statistical analysis involved pair sample t test, repeated measure ANOVA, Chi-square and Fisher's exact test.

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Zainab Khaliq Ansari

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

6 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.

Exclusion Criteria:

  • • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group 1 Single head toothbrush
Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.
Annen: Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control Trial
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
Eksperimentell: Group 2 Triple head toothbrush
Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.
Annen: Comparing the plaque removal ability of triple head tooth brush versus single head tooth brush among school based cerebral palsy children: A Randomized Control Trial
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plaque Index Score
Tidsramme: Before and after the intervention of four weeks
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
Before and after the intervention of four weeks
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
Tidsramme: At postintervention after four weeks.
At postintervention after four weeks.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DMFT/dmft index
Tidsramme: At Baseline
To assess dentition status
At Baseline
Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
Tidsramme: At Baseline
Brushing frequency, complain of pain and visit to a dentist during last 12 months.
At Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dow University of Health Sciences

Etterforskere

  • Studiestol: Nadia Shah, M.Sc,Mphil, Dow University of Health Sciences

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)

18. desember 2021

Primær fullføring (Faktiske)

11. mai 2022

Studiet fullført (Faktiske)

15. juli 2022

Datoer for studieregistrering

Først innsendt

5. september 2022

Først innsendt som oppfylte QC-kriteriene

9. september 2022

Først lagt ut (Faktiske)

13. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. september 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2022

Sist bekreftet

1. september 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DowUHS clnical trial

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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