The Chromatic Evaluation of Universal Nano-hybrid Composites

Healthy Lifestyle Clinical Trial

Official title:

The Chromatic Evaluation of Universal Nano-hybrid Composites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251921
• Other study ID #: 1032/55
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Corina Prodan, dr.
• Phone: 0040946981859
• Email: corinamirelaprodan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Procedure:
• Restoration
with resin-based composite

Locations

Country	Name	City	State
Romania	GlobalDent	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical inspection of the restorations	The blind observer will clinically inspect the restorations , following the Ryge scale criteria	24 hours
Primary	Clinical inspection of the restorations	The blind observer will clinically inspect the restorations , following the Ryge scale criteria	1 week
Primary	Clinical inspection of the restorations	The blind observer will clinically inspect the restorations , following the Ryge scale criteria	6 weeks
Primary	Clinical inspection of the restorations	The blind observer will clinically inspect the restorations , following the Ryge scale criteria	1 year