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A Study Comparing Fluoride-Based Fillings and Regular Composite Fillings for Back Teeth

A randomized controlled trial to evaluate the performance of posterior Class I restorations using fluoride-releasing dental restoratives and bulk fill composite resin in an Indian population: A double-blind split-mouth study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102610
Enrollment
50
Registered
2026-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

None listed

Interventions

Intervention1: Zirconomer, Cention N, Beautifil Bulk Restorative (Fluoride-releasing materials): Zirconomer Shofu Inc.
Japan, Cention N Ivoclar Vivadent
Schaan, Liechtenstein, Beautifil Bulk Shofu Inc.
Japan Control Intervention1: Filtek One Bulk-fill (Bulk-fill composite resin): Filtek One Bulk Fill - 3M ESPE
St Paul, MN, USA

Sponsors

TPCTs Terna Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with with at least four single-surface occlusal caries on their posterior teeth. Patients diagnosed with at least four ICDAS code 4 5 carious lesions (Class I) in Mature Permanent Molar teeth. Single surface-occlusal caries restricted to fissures and do not involve cusps that are vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; should be in occlusion with opposing natural teeth. Patients willing to come to follow-up appointments.

Exclusion criteria

Exclusion criteria: Morbid Individuals with Systemic Diseases. Decay involving Cusp, grossly carious teeth. Partially erupted teeth. Absence of antagonist teeth. Teeth with interproximal caries. Periodontally compromised teeth.

Design outcomes

Primary

MeasureTime frame
The clinical performance of the restorations evaluated using the modified USPHS criteria (including parameters such as marginal integrity, surface texture, color match, and secondary caries).Timepoint: The restorations will be assessed at: Baseline (immediately after placement), 4 weeks, and 8 weeks. These time intervals will help determine both short-term performance and early clinical behavior of the materials.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactAmeya Mahavir Lokhande

TPCTs Terna Dental College

thedentist222@gmail.com9561236222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026