N/A
N=48
Effectiveness of Customized Handle Toothbrush
Dental Plaque · Dental Prophylaxis · Dental Care
Bottom Line
View on ClinicalTrials.gov: NCT04845633 ↗Enrolled (actual)
48
Serious AEs
—
Results posted
Aug 2021
Primary outcome: Primary: Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline — 3.05; 3.19; 3.63; 3.41 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children (Other); Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children (Other); Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome (Other); Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Damascus University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline |
3.05; 3.19; 3.63; 3.41 | — |
| PRIMARY Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing |
1.7; .96; 2.69; .97 | — |
| SECONDARY Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week |
1.41; .38; 2.23; .52 | — |
Summary
People with special needs suffer from many difficulties, including mental, physical or motor, which increase the difficulty of obtaining good oral health.
Therefore, some adjustments must be made to help these patients maintain oral health.
The aim of the current research is to modify the traditional toothbrush grip by manufacturing a Customized Handle of every young child or people with special needs to improve oral health for those patients by relying on themselves with an effectively way.
Eligibility Criteria
Inclusion criteria
- Ages between 6-9 years old.
- Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.
- TMQHPI is at least 2.
- Cooperative participant (Positive according to Frankel's behavioral rating scale).
- Parents' consent.
- Participant with down syndrome must have been diagnosed by specialist.
Exclusion criteria
- Children undergoing orthodontic treatment.
- Allergic to any of the toothpaste ingredient used the study.
- Participant used any toothbrush other than the conventional brush before.
- Healthy children Participant with systemic diseases
- Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously.
Data sourced from ClinicalTrials.gov (NCT04845633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.