EFFECTIVENESS OF ONE DENTAL PREVENTIVE AGENT OVER ANOTHER IN PREVENTING DENTAL CARIES AMONG THALASSEMIA PATIENTS

EFFECTIVENESS OF TOPICAL 38% SILVER DIAMINE FLUORIDE WHEN COMPARED TO 25% SILVER NITRATE SOLUTION FOLLOWED BY FLUORIDE VARNISH IN ARRESTING AND PREVENTING DENTAL CARIES AMONG BETA THALASSEMIA MAJOR PATIENTS – A RANDOMIZED CLINICAL TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059838

Enrollment

170

Registered

2023-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: K023- Arrested dental caries Health Condition 2: D561- Beta thalassemia

Interventions

Intervention1: SILVER DIAMINE FLUORIDE (38% w/v, FAgamin): GROUP 1: SDF Dose per patient used will be 0.32 ml (6 drops), applied via topical oral application once per 6 months. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Thalassemia major patients enrolled in institution of Medicine (Hematology), Post graduate Institute of Medical Sciences, Rohtak, Haryana. 2. Patients aged above 18 years. 3. Thalassemia major patients with Nyvad score, 2 and 3 (active enamel and dentinal caries, respectively, not close to pulp). 4. Topical SDF and Silver nitrate followed by fluoride varnish will be applied only on labial/buccal, lingual/palatal & occlusal surfaces of all teeth. 5. At least 20 teeth present excluding 3rd molars or fully dentate patients will be included in study. 6. Patients who have given written consent for the study.

Exclusion criteria

Exclusion criteria: 1. Patients with other systemic disorders like serious or unstable cardiac, renal diseases, hypertensive, pulmonary, endocrine disorders. 2. Chronic smokers, alcohol or drug abusers. 3. Uncooperative patients and with known silver allergy. 4. Patients with reduced mouth opening. 5. Teeth which are grossly broken, with more than one- third of the crown structure missing or with pulpal involvement. 6. Presence of an abscess or sinus, obvious discolouration or premature hypermobility. 7. Pregnant women or lactating mothers. 8. Patient under immunosuppressive drugs.

Design outcomes

Primary

Measure	Time frame
Caries arrest rate , Caries Prevalence , Caries preventive fractionTimepoint: 3 and 6 months	—

Secondary

Measure	Time frame
patient satisfaction and acceptabilityTimepoint: 3 and 6 months	—

Countries

India

Contacts

Public ContactJAGREETI KAYASTH

POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK , HARYANA

vipulyadavv.97@gmail.com88263639611

Outcome results

None listed

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