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36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions

Primary Purpose

Root Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spectrum TPH3
Riva LC
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Caries focused on measuring micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Root caries lesions (at least 1mm depth)

Exclusion Criteria:

  • Complex medical history
  • Poor dental hygiene/infrequent practise of oral hygiene habits
  • Severe or chronic periodontitis
  • Extreme carious activity
  • Heavy bruxism
  • Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
  • Previously restored and abutment teeth for bridge or removable dental prostheses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Spectrum TPH3, tooth restoration

    Riva LC, restorative material

    Arm Description

    Restoration with micro hybrid resin composite

    Restoration with resin-modified glass ionomer cement

    Outcomes

    Primary Outcome Measures

    Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
    The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost). Clinical evaluation is performed to examine if the restorations are in place or fallen.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2018
    Last Updated
    July 11, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03722758
    Brief Title
    36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions
    Official Title
    Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 15, 2016 (Actual)
    Primary Completion Date
    July 15, 2018 (Actual)
    Study Completion Date
    November 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.
    Detailed Description
    The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions. Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Root Caries
    Keywords
    micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spectrum TPH3, tooth restoration
    Arm Type
    Active Comparator
    Arm Description
    Restoration with micro hybrid resin composite
    Arm Title
    Riva LC, restorative material
    Arm Type
    Active Comparator
    Arm Description
    Restoration with resin-modified glass ionomer cement
    Intervention Type
    Device
    Intervention Name(s)
    Spectrum TPH3
    Other Intervention Name(s)
    resin composite
    Intervention Description
    tooth restoration with two different restorative materials
    Intervention Type
    Device
    Intervention Name(s)
    Riva LC
    Other Intervention Name(s)
    RMGİC
    Intervention Description
    tooth restoration with two different restorative materials
    Primary Outcome Measure Information:
    Title
    Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
    Description
    The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost). Clinical evaluation is performed to examine if the restorations are in place or fallen.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Root caries lesions (at least 1mm depth) Exclusion Criteria: Complex medical history Poor dental hygiene/infrequent practise of oral hygiene habits Severe or chronic periodontitis Extreme carious activity Heavy bruxism Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm) Previously restored and abutment teeth for bridge or removable dental prostheses
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Uzay Koc-Vural
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions

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