How effective is chlorhexidine gluconate mouthwash compared to probiotic oral rinse on the oral fungal levels in children with Down Syndrome?

Efficacy of chlorhexidine gluconate versus probiotic oral rinse on the oral Candida albicans counts in children with Down Syndrome - A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046847

Enrollment

Registered

2022-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: Q909- Down syndrome, unspecified Health Condition 2: K137- Other and unspecified lesions of oral mucosa

Interventions

Intervention1: Prescription of Chlorhexidine gluconate or probiotic oral rinse to children with Down Syndrome: During the first dental visit (T0): Following will be performed: - World Health Organiza

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 - 14 years reporting to NITTE Special Child Care Center (N-SPECC) and Department of Pediatric and Preventive Dentistry of A B Shetty Memorial Institute of Dental Sciences, NITTE Deemed to be University diagnosed with Down Syndrome Down Syndrome children with good compliance and guardians who are well motivated. Down Syndrome children whose parents/guardians have given written consent.

Exclusion criteria

Exclusion criteria: Down Syndrome children with clinical symptoms of candidiasis. Down Syndrome children with known allergy to probiotic drugs/products, xylitol, sorbitol, maltodextrin and natural vanilla flavoring. Down Syndrome children with known genetic abnormalities or underlying systemic and metabolic disease and are on medication. Down Syndrome children undergoing specialized treatment, e.g., orthodontic treatment, wearing space maintainer or any other appliance. Down Syndrome children /parents unwilling to participate or who have not given consent.

Design outcomes

Primary

Measure	Time frame
The aim of the study is to quantify and compare the colonies of Candida albicans present in oral swab samples collected from Down Syndrome children before and after use of chlorhexidine gluconate and probiotic oral rinse.Timepoint: 1 month	—

Secondary

Measure	Time frame
- To quantify the levels of Candida albicans in Down Syndrome children with the usage of microencapsulated sugar free probiotic oral rinse. - To quantify the level of Candida albicans in Down Syndrome children with the usage of 0.2% w/v Chlorhexidine gluconate oral rinse. - To evaluate and correlate the effect of using the microencapsulated sugar free probiotic oral rinse and 0.2% w/v Chlorhexidine gluconate oral rinse on Candida albicans level in Down Syndrome children. Timepoint: 1 month	—

Measure

Time frame

- To quantify the levels of Candida albicans in Down Syndrome children with the usage of microencapsulated sugar free probiotic oral rinse. - To quantify the level of Candida albicans in Down Syndrome children with the usage of 0.2% w/v Chlorhexidine gluconate oral rinse. - To evaluate and correlate the effect of using the microencapsulated sugar free probiotic oral rinse and 0.2% w/v Chlorhexidine gluconate oral rinse on Candida albicans level in Down Syndrome children. Timepoint: 1 month

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Countries

India

Contacts

Public ContactDr Swagata Saha

A B Shetty Memorial Institute of Dental Sciences

hod.pedo.absmids@nitte.edu.in9880309703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026