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The Chromatic Evaluation of Universal Nano-hybrid Composites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06251921
Recruitment Status : Recruiting
First Posted : February 9, 2024
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
Prodan Corina Mirela, Iuliu Hatieganu University of Medicine and Pharmacy

Tracking Information
First Submitted Date  ICMJE January 28, 2024
First Posted Date  ICMJE February 9, 2024
Last Update Posted Date February 9, 2024
Actual Study Start Date  ICMJE January 23, 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2024)
  • Clinical inspection of the restorations [ Time Frame: 24 hours ]
    The blind observer will clinically inspect the restorations , following the Ryge scale criteria
  • Clinical inspection of the restorations [ Time Frame: 1 week ]
    The blind observer will clinically inspect the restorations , following the Ryge scale criteria
  • Clinical inspection of the restorations [ Time Frame: 6 weeks ]
    The blind observer will clinically inspect the restorations , following the Ryge scale criteria
  • Clinical inspection of the restorations [ Time Frame: 1 year ]
    The blind observer will clinically inspect the restorations , following the Ryge scale criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Chromatic Evaluation of Universal Nano-hybrid Composites
Official Title  ICMJE The Chromatic Evaluation of Universal Nano-hybrid Composites
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Lifestyle
Intervention  ICMJE Procedure: Restoration
with resin-based composite
Study Arms  ICMJE
  • Experimental: Restorations 1
    preheated resin-based composite
    Intervention: Procedure: Restoration
  • Experimental: Restorations 2
    room temperature resin-based composite
    Intervention: Procedure: Restoration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2024)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Corina Prodan, dr. 0040946981859 corinamirelaprodan@gmail.com
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06251921
Other Study ID Numbers  ICMJE 1032/55
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data collected will be used to publish in a publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 1 year after the data is collected
Access Criteria: the data will be provided to the statistician
Current Responsible Party Prodan Corina Mirela, Iuliu Hatieganu University of Medicine and Pharmacy
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Iuliu Hatieganu University of Medicine and Pharmacy
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Diana Dudea, DDS Iuliu Hațeganu University of Medicine and Pharmacy
PRS Account Iuliu Hatieganu University of Medicine and Pharmacy
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP