Effect of fluoride varnish and saliva substitute on tooth decay after radiotherapy in head and neck cancer patients

A Randomized Control Trial Comparing the Effect of Salivary Substitute And Fluoride Varnish on Radiation Caries in Irradiated Head And Neck Cancer Patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010723

Enrollment

200

Registered

2017-11-30

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- Head and neck cancer patients who will be requiring radiotherapy Health Condition 2: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: Saliva Substitute and fluoride varnish: Both agents will be applied topically before radiotherapy, then at three monthly interval after radiotherapy for one and half years. In cases of

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with head and neck cancer where salivary glands are in the field of radiation 2. Maintainable oral hygiene

Exclusion criteria

Exclusion criteria: 1. Edentulism 2. History of drug abuse 3. History of the use of saliva-reducing medications. 4. Poor manual dexterity to maintain oral hygiene. 5. Non maintainable periodontal status

Design outcomes

Primary

Measure	Time frame
Decrease in the radiation caries incidence by 15-20%Timepoint: In one year	—

Secondary

Measure	Time frame
Incease in Ph of the saliva towards neutral, incease in buffering capacity of saliva, decreased discomfort due to xerostomiaTimepoint: In 6 months and improving with time	—

Countries

India

Contacts

Public ContactDr Sudhir Bhandari

PGIMER

drsudhirbhandari@yahoo.co.in9501866133

Outcome results

None listed

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