Does application of chitosan varnish reduce food debris accumulation around orthodontic braces?

To compare the biofilm formation following the application of Chitosan varnish or Chlorhexidine varnish in patients undergoing fixed orthodontic treatment: A double blinded randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018896

Enrollment

120

Registered

2019-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Malocclusion Health Condition 2: R688- Other general symptoms and signs

Interventions

Intervention1: Chitosan varnish: Naturally derived biological agent used as varnish. Applied weekly for 6 weeks Control Intervention1: Chlorhexidine varnish: Cervitec F, Ivolcar varnish. Applied weekl

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients undergoing fixed orthodontic therapy in the age group of 16 - 32 years 2. Maxillary arch with permanent dentition. 3. Patients undergoing orthodontic treatment with fixed appliances with conventional metal brackets. 4. Patients with good oral hygiene and with no incipient carious lesion. 5. Patients providing informed consent 6. Patients under 18 years informed consent will be obtained from their parents.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic diseases, fluorosis. 2. Patients on metal self-ligating or ceramic brackets. 3. Patients with periodontitis with probing depth > 4mm 4. Patients taking antibiotics 3 months prior to the study 5. Smokers, pregnant ladies. 6. Patient with cleft lip, cleft palate and other dento-facial abnormalities. 7. Other oral fixed appliances.

Design outcomes

Primary

Measure	Time frame
Assessment of biofilm formation using Bonded Bracket Index (Plaque index) following the use of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.Timepoint: 0 Week (T0) 1 Week (T1) 2 Weeks (T2) 3 Weeks (T3) 4 Weeks (T4) 5 Weeks (T5) 6 Weeks (T6)	—

Secondary

Measure	Time frame
a. Quantitative assessment of S. mutans following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy. b. Estimation of plaque pH following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy. Timepoint: 0 Week (T0) 1 Week (T1) 2 Weeks (T2) 3 Weeks (T3) 4 Weeks (T4) 5 Weeks (T5) 6 Weeks (T6)	—

Measure

Time frame

a. Quantitative assessment of S. mutans following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy. b. Estimation of plaque pH following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy. Timepoint: 0 Week (T0) 1 Week (T1) 2 Weeks (T2) 3 Weeks (T3) 4 Weeks (T4) 5 Weeks (T5) 6 Weeks (T6)

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Countries

India

Contacts

Public ContactJogikalmat Krithikadatta

Dept of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College

drkrithikadatta@hotmail.com9840111369

Outcome results

None listed

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