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5-year Clinical Evaluation of Cavity Lining on the Restoration

Primary Purpose

Teeth; Lesion, Dental Root Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass Liner
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth; Lesion focused on measuring Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface

Exclusion Criteria:

  • Patients who were under the age of 18 years
  • Complex medical history
  • Severe or chronic periodontitis
  • Extreme carious activity
  • Heavy bruxism
  • Very deep or superficial carious lesions
  • Previously restored and abutment teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Glass Liner

    No liner

    Arm Description

    Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin

    Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin

    Outcomes

    Primary Outcome Measures

    Retention Outcome
    1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2019
    Last Updated
    January 9, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03802539
    Brief Title
    5-year Clinical Evaluation of Cavity Lining on the Restoration
    Official Title
    5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    January 1, 2020 (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
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.
    Detailed Description
    Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann & Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (P < 0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Teeth; Lesion, Dental Root Caries
    Keywords
    Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Glass Liner
    Arm Type
    Experimental
    Arm Description
    Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
    Arm Title
    No liner
    Arm Type
    No Intervention
    Arm Description
    Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin
    Intervention Type
    Device
    Intervention Name(s)
    Glass Liner
    Intervention Description
    restoration of root caries according to two different protocols
    Primary Outcome Measure Information:
    Title
    Retention Outcome
    Description
    1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface Exclusion Criteria: Patients who were under the age of 18 years Complex medical history Severe or chronic periodontitis Extreme carious activity Heavy bruxism Very deep or superficial carious lesions Previously restored and abutment teeth

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31273529
    Citation
    Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020 Feb;24(2):979-989. doi: 10.1007/s00784-019-03001-z. Epub 2019 Jul 4.
    Results Reference
    derived

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    5-year Clinical Evaluation of Cavity Lining on the Restoration

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