5-year Clinical Evaluation of Cavity Lining on the Restoration

NCT ID: NCT03802539

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2020-01-01

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).

Conditions

Teeth; Lesion; Dental Root Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glass Liner

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

Group Type: EXPERIMENTAL

Glass Liner

Intervention Type: DEVICE

restoration of root caries according to two different protocols

No liner

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Glass Liner

restoration of root caries according to two different protocols

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Uzay Koc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31273529 (View on PubMed)

Other Identifiers

HEK 11/54-8

Identifier Type: -

Identifier Source: org_study_id