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Comparison of Two Advanced tooth fillings: A Clinical Study

Comparative evaluation of the clinical performance of an Alkasite restorative material and Bulk fill composite for class II restoration in primary molars - A Randomized Clinical Trial - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082909
Enrollment
26
Registered
2025-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Alkasite tooth restoration or filling: In each patient, restoration of a class 2 carious tooth in primary molar using an alkasite restorative material on one side of the mouth and check

Sponsors

Dr Aisha Yenepoya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in the age group of 4-9 years presenting with proximal carious lesions on primary maxillary or mandibular molars on either side (bilateral) of the arch. Presence of two class II carious lesions on maxillary or mandibular primary molars, with no signs of pulpitis or necrosis bilaterally. The ICDAS score of the caries has to be lower than 5 (visible dentin in a distinct cavity) and the caries score of 2.1-2.2 according to the Graham J Mount classification. Cavities with buccolingual width that involved less than 2/3 of the intercuspal distance or required cusp coverage

Exclusion criteria

Exclusion criteria: Behaviorally uncooperative children Children with special health care needs with intellectual disabilities Children with parafunctional habits like bruxism Teeth with proximal cavities that involved more than two surfaces Children with habitual chewing on unilateral side Inadvertent pulp exposure during cavity preparation Lack of gingival seat area

Design outcomes

Primary

MeasureTime frame
Clinical success rate of Alkasite and Bulk fill composite restorative material in pediatric dentistry interms of esthetic, functional and biological properties.Timepoint: one year

Secondary

MeasureTime frame
Clinical success rate of Alkasite restoration compared it with Bulk fill composite restoration.Timepoint: one year

Countries

India

Contacts

Public ContactDr Aisha Yenepoya

Yenepoya Dental College

sharansargod@yahoo.co.in9845120885

Outcome results

None listed

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