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Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT05500547
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

Condition or Disease Intervention/Treatment Phase
  • Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
 N/A

Detailed Description

One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Actual Study Start Date :
Jul 15, 2021
Actual Primary Completion Date :
Jul 15, 2022
Actual Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Universal single shade resin composite restorative material

Dental restorative material

Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.
Other Names:
  • assessment of Universal single shade resin composite and Nano-hybrid multi-shade resin composite restorative material using the US Public Health Service "USPSH" criteria

    		•
    Active Comparator: Nano-hybrid multi-shade resin composite restorative material

    Dental restorative material

    Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
    US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.
    Other Names:
  • assessment of Universal single shade resin composite and Nano-hybrid multi-shade resin composite restorative material using the US Public Health Service "USPSH" criteria

    		•

    Outcome Measures

    Primary Outcome Measures

    1. USPSH criteria [For 9 months]

      Alpha and Beta are clinically successful, Charlie and Delta are clinically failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • • They should have an acceptable oral hygiene level.

    • Presence of at least two occlusal carious lesions to be restored with two different types of composite.

    • The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.

    • Age range between 25 and 45years.

    Exclusion Criteria:

    • • Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion

    • Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.

    • Alcoholic and smoker patients.

    • Patients had participated in a clinical trial within 6 months before commencement of this trial.

    • Patients unable to return for recall appointment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruba Salah Anwar Minya Egypt 61511

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Study Director: Mona I Riad, Prof, Minia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ruba Salah Anwar, Assistant Lecturer at Department of Operative Dentistry, Faculty of Dentistry, Minia University
    ClinicalTrials.gov Identifier:
    NCT05500547
    Other Study ID Numbers:
    • RSAnwar
    First Posted:
    Aug 15, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Aug 15, 2022