CTRI/2023/11/059838Not yet recruitingPhase 4
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 TRIA
MATERIAL CONSUMABLE and INFRASTRUCTURE AND INSTITUTIONAL SUPPORT0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Investigators
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