The Chromatic Evaluation of Universal Nano-hybrid Composites

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Enrolling

Conditions: Healthy Lifestyle

Treatments: Procedure: Restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT06251921

1032/55

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the preheating effect of a group shade resin-based composite. The evaluation will be done on Ryge criteria. The main question it aims to answer is if there is a difference in time between preheated and non-heated resin-based composites in the oral cavity. Participants will be given treatment for cavities class 2 on premolars and molar and will come for recall at 24h, 1 week, 6 weeks, 3 months, 6 months, and 1 year.

Full description

The participants in the study will be adult patients (over 18 years old). Each patient will receive 2 restorations on premolars or molars, class 2, and medium cavities. The restorations will be performed under isolation with rubber-dam, and restored with preheated or not-heated resin-based composite. The occlusion will be tested and they will be notified to come for recall in order to make the evaluation of the restorations.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Permanent dentition
• The OHI index = 0
• Non-smoking patient
• The patient has a healthy diet
• The patient has parafunction
• The antagonist tooth is healthy / with direct restorations
• The caries are situated on proximal surfaces on premolars, molars
• The cavities have a medium depth

Exclusion criteria

• Temporary dentition
• The OHI index >= 1
• The patient is smoker
• The patient has an unhealthy diet
• The patient suffers from bruxism, clenching
• The antagonist tooth has an indirect restoration
• The caries are situated on canines or incisors
• The cavities have a deep or shallow depth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Restorations 1

Experimental group

Description:

preheated resin-based composite

Treatment:

Procedure: Restoration

Restorations 2

Experimental group

Description:

room temperature resin-based composite

Treatment:

Procedure: Restoration