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5-year Clinical Evaluation of Cavity Lining on the Restoration

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. Read our disclaimer for details. Identifier: NCT03802539
Recruitment Status : Active, not recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
Uzay Koc, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Teeth; Lesion Dental Root Caries Device: Glass Liner Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : July 1, 2016
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Glass Liner
Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
Device: Glass Liner
restoration of root caries according to two different protocols

No Intervention: No liner
Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin

Primary Outcome Measures :
  1. Retention Outcome [ Time Frame: 5 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Uzay Koc, Principal Investigator, Hacettepe University Identifier: NCT03802539    
Other Study ID Numbers: HEK 11/54-8
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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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
Keywords provided by Uzay Koc, Hacettepe University:
Root caries
Cavity lining
Composite resin restorations
Self-etch adhesive
Additional relevant MeSH terms:
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Root Caries
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases