5-year Clinical Evaluation of Cavity Lining on the Restoration

Hacettepe University

Status: Unknown

Conditions: Teeth; Lesion; Dental Root Caries

Treatments: Device: Glass Liner

Study type: Interventional

Funder types: Other

Identifiers

NCT03802539

HEK 11/54-8

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Glass Liner

Experimental group

Description:

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

Treatment:

Device: Glass Liner

No liner

No Intervention group

Description:

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