Usefulness of customized toothbrush and commercial toothbrushes in improving oral hygiene among children with special needs

Effectiveness of Indigenous customized toothbrush versus commercially available toothbrushes in improving oral hygiene among Intellectually disabled children – a Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070077

Enrollment

Registered

2024-07-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K051- Chronic gingivitis Health Condition 2: F70- Mild intellectual disabilities Health Condition 3: F71- Moderate intellectual disabilities

Interventions

Intervention1: Indigenous customized toothbrush: The children will be performing parent or caregiver assisted toothbrushing 2 times daily for 14 days and supervised toothbrushing for 3 months using in

Eligibility

Inclusion criteria

Inclusion criteria: Study subjects aged 6 to 18 years in the mixed and permanent dentition Study subjects having ID categorized as limit IQ as mild or moderate Study subjects being part of psychosocial support groups under the supervision of a trained monitor Study subjects with plaque induced gingivitis

Exclusion criteria

Exclusion criteria: Subjects suffering from chronic debilitating conditions like Epilepsy Down syndrome etc and on long term medications which could influence their oral status Subjects with history of receiving antibiotic and antiseptic therapy Subjects with physical disabilities impaired motor functions non compliant behaviour etc Subjects who are not willing to participate and did not give informed consent and assent Patients with true periodontal pockets Subjects undergoing fixed orthodontic therapy

Design outcomes

Primary

Measure	Time frame
Effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled childrenTimepoint: 3 months	—

Secondary

Measure	Time frame
Effectiveness of indigenous customized toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months;Effectiveness of manual toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months;Effectiveness of sonic powered toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months	—

Measure

Time frame

Effectiveness of indigenous customized toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months;Effectiveness of manual toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months;Effectiveness of sonic powered toothbrush on TMQHPI scores and GI scores among intellectually disabled childrenTimepoint: 14 days, 1 month & 3 months

—

Countries

India

Contacts

Public ContactDr Senthil M

Indira Gandhi Institute of Dental Sciences

senthilm@igids.ac.in9486365954

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026