The Chromatic Evaluation of Universal Nano-hybrid Composites

I

Iuliu Hatieganu University of Medicine and Pharmacy

Status

Enrolling

Conditions

Healthy Lifestyle

Treatments

Procedure: Restoration

Study type

Interventional

Funder types

Other

Identifiers

NCT06251921
1032/55

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Restorations 1
Experimental group
Description:
preheated resin-based composite
Treatment:
Procedure: Restoration
Restorations 2
Experimental group
Description:
room temperature resin-based composite
Treatment:
Procedure: Restoration

Trial contacts and locations

1

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Central trial contact

Corina Prodan, dr.

Data sourced from clinicaltrials.gov

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