5-year Clinical Evaluation of Cavity Lining on the Restoration

Not Applicable

• Conditions: Teeth; Lesion; Dental Root Caries
• Interventions: Device: Glass Liner

• Registration Number: NCT03802539
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-07-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Study First Posted: 2019-01-14
• Last Update Posted: 2019-01-14
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Glass Liner	Glass Liner	Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin

Primary Outcome Measures

Name	Time	Method
Retention Outcome	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.