Comparison of Fluoride Mouth rinse and Chlorhexidine for Prevention of white spot lesions during fixed Orthodontic treatment

Comparison of Fluoride Mouth rinse and Chlorhexidine for prevention of white spot lesions during fixed orthodontic treatment: Prospective blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104116

Enrollment

Registered

2026-02-17

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: K026- Dental caries on smooth surface

Interventions

Intervention1: Fluoride Mouth rinse: Fluoride Mouth rinse at night time after dinner for six month Control Intervention1: Chlorhexidine Mouthrinse: Chlorhexidine Mouthrinse at night time after dinner

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient appointment given for fixed orthodontic treatment. 2. The patient having age group of 14 to 25, having good oral hygiene. 3. The patient having no habit of smoking with no systemic medical condition.

Exclusion criteria

Exclusion criteria: 1. Those patients received previous orthodontic treatment. 2. More than 2 carious cavity 3. Enamel abnormality prior to treatment 4. Any Pregnant female or Mentally retarded patient

Design outcomes

Primary

Measure	Time frame
The primary outcome will be estimation of White spot lesion on patient level assessed from digital photographs. The white spot lesion index9 (Gorelick et al,1982) 0-No visible white spot lesion (No demineralization) 1-Visible WSL that covered less than 1/3rd of the tooth surface.(Mild demineralization) 2-Visible WSL that covered more than 1/3rd of the tooth surface, with a roughened surface.(Moderate demineralization) 3-Visible cavitations requiring restoration.( Severe demineralization) Timepoint: 6 month of orthodontic treatment with use of mouthrinse at night time.	—

Measure

Time frame

The primary outcome will be estimation of White spot lesion on patient level assessed from digital photographs. The white spot lesion index9 (Gorelick et al,1982) 0-No visible white spot lesion (No demineralization) 1-Visible WSL that covered less than 1/3rd of the tooth surface.(Mild demineralization) 2-Visible WSL that covered more than 1/3rd of the tooth surface, with a roughened surface.(Moderate demineralization) 3-Visible cavitations requiring restoration.( Severe demineralization) Timepoint: 6 month of orthodontic treatment with use of mouthrinse at night time.

—

Secondary

Measure	Time frame
Bleeding from GumTimepoint: 6 month of Fixed orthodontic Treatment	—

Countries

India

Contacts

Public ContactDr Awanindra Kumar Jha

Rajendra Institute of Medical Sciences

drakjha007@gmail.com8676054766

Outcome results

None listed

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