The Chromatic Evaluation of Universal Nano-hybrid Composites

NCT ID: NCT06251921

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restorations 1

preheated resin-based composite

Group Type EXPERIMENTAL

Restoration

Intervention Type PROCEDURE

with resin-based composite

Restorations 2

room temperature resin-based composite

Group Type EXPERIMENTAL

Restoration

Intervention Type PROCEDURE

with resin-based composite

Interventions

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Restoration

with resin-based composite

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Prodan Corina Mirela

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana Dudea, DDS

Role: STUDY_DIRECTOR

Iuliu Hațeganu University of Medicine and Pharmacy

Locations

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GlobalDent

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Corina Prodan, dr.

Role: CONTACT

0040946981859

Facility Contacts

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Corina Prodan, dr

Role: primary

0040746981859

Other Identifiers

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1032/55

Identifier Type: -

Identifier Source: org_study_id

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