Clinical trial NCT05768568: Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
Official title: Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Mixed
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions
Primary purpose: PREVENTION

Brief summary: CHildren of Cerebral Palsy(CP) are at high risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth.inability to perform coordinated movements too makes brushing very difficult and hence it worsens the oral hygiene status.

Hence the objective of the study is to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who meet inclusion exclusion criteria will be assessed at different time intervals via Oral hygiene index simplified (OHI-S), plaque index (PI) and gingival index (GI) Scores will be compared and analyzed from baseline, after first phase and after second phase of interventions.

Detailed description: Children with cerebral palsy manifests neurologically associated muscular dysfunction. They face difficulty in maintaining posture, gait and locomotion, leading to restricted movements. They are at a higher risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth. The main cause of dental diseases in CP is ineffective removal of dental plaque. This is due to lack of motor and neuromuscular dysfunction with an inability to understand and comprehend oral hygiene instructions and unable to carryout well-coordinated movements for instance tooth brushing. In a disadvantaged population interventions should be introduced at an early phase of life encouraging it to become part of CP child's daily oral hygiene maintenance regime.

Hence the objective of the study was designed to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival \& plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks,will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions. Repeated measures two way ANOVA with Post Hoc Tukey test. Repeated measures two way ANOVA with Post Hoc Tukey test will be applied on mean GI, PI and OHI-S. Results of phase-I and phase-II will be compared and analyzed

Eligibility criteria: Inclusion Criteria:

1. CP Children aged 12-15 years
2. CP children with OHI-S score \>1.3 and GI score \>1 \& PI score \>1
3. Subjects with positive consent from schools and parents
4. Presence of at least 20 teeth in the mouth
5. Independent (mild) CP patients - who are able to perform tooth brushing under supervision assessed by caregiver's account of daily activities.
6. Mentally stable

Exclusion Criteria:

1. Inability to cooperate with the oral examination
2. Severe neuromuscular incoordination
3. Reluctant or Unable to comprehend consent /or withdrawal of consent
4. Participant with calculus deposits at baseline
5. Lack of Manual dexterity to perform oral hygiene
6. Underlying systemic disease
7. Participant requiring emergency dental treatment

Primary outcomes:
measure: Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)
timeFrame: 3 months
measure: Oral Hygiene Status assessed by Gingival Index (GI)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Al Umeed Rehabilitation Association (AURA)
state: Sindh
Study officials:
affiliation: Dow University
name: Mohsin Haider, BDS
role: PRINCIPAL_INVESTIGATOR
References: