"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children
9 settembre 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
70
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Sindh
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Karachi, Sindh, Pakistan, 75300
- Zainab Khaliq Ansari
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 6 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group 1 Single head toothbrush
Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.
|
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
|
|
Sperimentale: Group 2 Triple head toothbrush
Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.
|
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Plaque Index Score
Lasso di tempo: 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.
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Before and after the intervention of four weeks
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Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
Lasso di tempo: At postintervention after four weeks.
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At postintervention after four weeks.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
DMFT/dmft index
Lasso di tempo: At Baseline
|
To assess dentition status
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At Baseline
|
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Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
Lasso di tempo: At Baseline
|
Brushing frequency, complain of pain and visit to a dentist during last 12 months.
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At Baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Cattedra di studio: Nadia Shah, M.Sc,Mphil, Dow University of Health Sciences
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
18 dicembre 2021
Completamento primario (Effettivo)
11 maggio 2022
Completamento dello studio (Effettivo)
15 luglio 2022
Date di iscrizione allo studio
Primo inviato
5 settembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
9 settembre 2022
Primo Inserito (Effettivo)
13 settembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 settembre 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 settembre 2022
Ultimo verificato
1 settembre 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DowUHS clnical trial
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .