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

9 september 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1 Single head toothbrush
Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.
Ander: 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.
Experimenteel: Group 2 Triple head toothbrush
Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plaque Index Score
Tijdsspanne: 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.
Tijdsspanne: At postintervention after four weeks.
At postintervention after four weeks.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DMFT/dmft index
Tijdsspanne: 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
Tijdsspanne: At Baseline
Brushing frequency, complain of pain and visit to a dentist during last 12 months.
At Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dow University of Health Sciences

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 december 2021

Primaire voltooiing (Werkelijk)

11 mei 2022

Studie voltooiing (Werkelijk)

15 juli 2022

Studieregistratiedata

Eerst ingediend

5 september 2022

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2022

Eerst geplaatst (Werkelijk)

13 september 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 september 2022

Laatste update ingediend die voldeed aan QC-criteria

9 september 2022

Laatst geverifieerd

1 september 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DowUHS clnical trial

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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