The Chromatic Evaluation of Universal Nano-hybrid Composites

NCT06251921 | Recruiting

• 1 other identifier: 1032/55
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Keywords

resin-based composite; color; pre-heated

Outcome Measures

Primary Outcomes (4)

• Clinical inspection of the restorations

  The blind observer will clinically inspect the restorations , following the Ryge scale criteria

  24 hours

• Clinical inspection of the restorations

  The blind observer will clinically inspect the restorations , following the Ryge scale criteria

  1 week

• Clinical inspection of the restorations

  The blind observer will clinically inspect the restorations , following the Ryge scale criteria

  6 weeks

• Clinical inspection of the restorations

  The blind observer will clinically inspect the restorations , following the Ryge scale criteria

  1 year

Study Arms (2)

Restorations 1

EXPERIMENTAL

preheated resin-based composite

Procedure: Restoration

Restorations 2

EXPERIMENTAL

room temperature resin-based composite

Procedure: Restoration

Interventions

Restoration PROCEDURE

with resin-based composite

Restorations 1; Restorations 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

GlobalDent

Cluj-Napoca, Cluj, 400352, Romania

RECRUITING

Study Officials

• Diana Dudea, DDS

  Iuliu Hațeganu University of Medicine and Pharmacy

  STUDY DIRECTOR

Central Study Contacts

Corina Prodan, dr.

CONTACT

0040946981859; corinamirelaprodan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 9, 2024
• Study Start: January 23, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after the data is collected
• Access Criteria: the data will be provided to the statistician

Locations

RO (1)