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To compare arginine sodium flouride varnish with sodium flouride varnish in prevention of dental caries among beta thalassemia patients

Effectiveness Of 2 percent Arginine-Sodium Fluoride Varnish Versus 5 percent Sodium Fluoride Varnish in Prevention Of Dental Caries Among Beta Thalassemia Major Patients: A Double Blind Randomized Control Trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086803
Enrollment
60
Registered
2025-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: Arginine Sodium flouride varnish: 2% Arginine mixed with 5% Sodium flouride varnishfrom baseline to 9 months (quarterly/ biannually) Control Intervention1: Sodium Flouride varnish: 5%

Sponsors

Dr Shubhangi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Beta thalassemia major participants enrolled from the department of medicine (Hematology), Post Graduate Institute of Medical Sciences, Rohtak , Haryana. 2. Participants aged between 12 years and 45 years. 3. Participants who gave written consent for the study. 4.Beta Thalassemia major participants with Nyvad and ICDAS score 2 and 3.

Exclusion criteria

Exclusion criteria: 1.Participants with other systemic disorders like serious or unstable cardiac, renal diseases, hypertensive, pulmonary, endocrine disorders. 2. Teeth with pulp involvement. 3. Presence of an abscess or sinus , obvious discolouration or premature hypermobility . 4. Patients under immunosuppressive drugs. 5.Patients who will not give consent. 6. Uncooperative patients.

Design outcomes

Primary

MeasureTime frame
Caries arrest rate from baseline using Nyvad Criteria and ICDAS at 6, and 12 months. Incidence of dental caries at 6 and 12 months. Biochemical changes i.e. salivary urea, iron, pH and TBARS at 3,6, 9 and 12 months. 4.Caries preventive fraction at 6 and 12 months. 5.Change in salivary Streptococcus mutans and Streptococcus sanguis count at 6 and 12 months.Timepoint: 0,3,6,9,12months

Secondary

MeasureTime frame
1.The patient satisfaction & acceptability of the preventive treatment & any side effects if any will be recorded. 2. The number needed to treat & the Intention to treat is calculatedTimepoint: baseline, 3,6,9,12 months

Countries

India

Contacts

Public ContactShubhangi

Postgraduate Institute of Dental Sciences, Rohtak

vipulyadavv.97@gmail.com8826363961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026