The Chromatic Evaluation of Universal Nano-hybrid Composites

February 8, 2024 updated by: Prodan Corina Mirela, Iuliu Hatieganu University of Medicine and Pharmacy
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restorations 1
preheated resin-based composite
with resin-based composite
Experimental: Restorations 2
room temperature resin-based composite
with resin-based composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical inspection of the restorations
Time Frame: 24 hours
The blind observer will clinically inspect the restorations , following the Ryge scale criteria
24 hours
Clinical inspection of the restorations
Time Frame: 1 week
The blind observer will clinically inspect the restorations , following the Ryge scale criteria
1 week
Clinical inspection of the restorations
Time Frame: 6 weeks
The blind observer will clinically inspect the restorations , following the Ryge scale criteria
6 weeks
Clinical inspection of the restorations
Time Frame: 1 year
The blind observer will clinically inspect the restorations , following the Ryge scale criteria
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Diana Dudea, DDS, Iuliu Hațeganu University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1032/55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data collected will be used to publish in a publication

IPD Sharing Time Frame

1 year after the data is collected

IPD Sharing Access Criteria

the data will be provided to the statistician

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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