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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- TPCTs Terna Dental College
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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).
Overview
Brief Summary
The primary purpose of this protocol is to evaluate and compare the clinical performance of three fluoride-releasing restorative materials (Zirconomer, Cention N, and Beautifil Bulk Restorative) with a bulk-fill composite resin (Filtek One Bulk-fill) in Class I occlusal restorations of permanent molars over a 24-month period in an Indian population. The study aims to assess the restorations using revised FDI criteria, focusing on aesthetic, functional, and biological outcomes.
Null hypothesis:
There is no difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.
Alternate hypothesis:
There is a difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 19.00 Year(s) to 53.00 Year(s) (—)
- Sex
- All
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
- •Morbid Individuals with Systemic Diseases.
- •Decay involving Cusp, grossly carious teeth.
- •Partially erupted teeth.
- •Absence of antagonist teeth.
- •Teeth with interproximal caries.
Outcomes
Primary Outcomes
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).
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Ameya Mahavir Lokhande
TPCTs Terna Dental College