A Study Comparing Three Types of Toothbrushes for Cleaning Teeth and Improving Gum Health in Hearing-Impaired Children Aged 8 12 Years

Comparison of Plaque Removal Efficacy and Improvement of Gingival Health Between Powered Toothbrush, Triple-Headed and Single-Headed Manual Toothbrushes in 8 12-Year-Old Auditory Impaired Children: A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104793

Enrollment

Registered

2026-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: K050- Acute gingivitis

Interventions

Intervention1: Powered toothbrush: Ethical approval was obtained prior to the study. Written informed consent from parents/guardians and assent from children will be obtained. Baseline plaque and gin

Eligibility

Inclusion criteria

Inclusion criteria: Children with auditory impairments aged 8 to 12. Self-sufficiency in brushing teeth. It was decided to brush twice a day. Relying solely on teeth brushing for oral hygiene.

Exclusion criteria

Exclusion criteria: Patients with extensive caries or oral lesions that make toothbrushing difficult. Any prior history of a systemic illness. A neurological or physical disorder that limits the manual dexterity needed to brush teeth. A patient receiving treatment for fixed orthodontics. Removable or fixed dental prostheses.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study will be the change in dental plaque score from baseline to 2 weeks, assessed using the Turesky Gilmore Glickman modification of the Quigley Hein Plaque Index. Plaque scores will be recorded at baseline (after oral prophylaxis) and at the end of 2 weeks. The outcome will be evaluated as: 1. Mean reduction in plaque score within each group (intragroup comparison). 2.Mean difference in plaque score among the three groups (intergroup comparison).Timepoint: Baseline 2 weeks	—

Measure

Time frame

The primary outcome of the study will be the change in dental plaque score from baseline to 2 weeks, assessed using the Turesky Gilmore Glickman modification of the Quigley Hein Plaque Index. Plaque scores will be recorded at baseline (after oral prophylaxis) and at the end of 2 weeks. The outcome will be evaluated as: 1. Mean reduction in plaque score within each group (intragroup comparison). 2.Mean difference in plaque score among the three groups (intergroup comparison).Timepoint: Baseline 2 weeks

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Secondary

Measure	Time frame
The secondary outcome will be the change in gingival health status from baseline to 2 weeks, assessed using the Gingival Index (L e & Silness, 1963). Gingival scores will be recorded at baseline & after 2 weeks. The outcome will be analyzed as: 1.Mean reduction in gingival index score within each group. 2. Comparison of mean gingival index scores between the three study groups.Timepoint: Baseline 2 weeks	—

Measure

Time frame

The secondary outcome will be the change in gingival health status from baseline to 2 weeks, assessed using the Gingival Index (L e & Silness, 1963). Gingival scores will be recorded at baseline & after 2 weeks. The outcome will be analyzed as: 1.Mean reduction in gingival index score within each group. 2. Comparison of mean gingival index scores between the three study groups.Timepoint: Baseline 2 weeks

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Countries

India

Contacts

Public ContactSharvari Ingle

SMBT Dental College and Hospital, Sangamner

vinayakumar53@gmail.com8830483436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026