5-year Clinical Evaluation of Cavity Lining on the Restoration

Study Overview
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Brief Summary
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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
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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).

Official Title
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5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial

Conditions
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Teeth; Lesion, Dental Root Caries

Intervention / Treatment
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* Device: Glass Liner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glass Liner<br>Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin | Device: Glass Liner<br>* restoration of root caries according to two different protocols<br>|
| No Intervention: No liner<br>Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive