The Chromatic Evaluation of Universal Nano-hybrid Composites

Not Applicable

Recruiting

• Conditions: Healthy Lifestyle
• Interventions: Procedure: Restoration

• Registration Number: NCT06251921
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-01-28
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-08
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restorations 2	Restoration	room temperature resin-based composite
Restorations 1	Restoration	preheated resin-based composite

Primary Outcome Measures

Name	Time	Method
Clinical inspection of the restorations	1 year	The blind observer will clinically inspect the restorations , following the Ryge scale criteria

Trial Locations

Locations (1)

GlobalDent; 🇷🇴 Cluj-Napoca, Cluj, Romania