5-year Clinical Evaluation of Cavity Lining on the Restoration

Teeth; Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03802539
• Other study ID #: HEK 11/54-8
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: January 1, 2020
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Root Caries
• Root Caries
• Teeth; Lesion

Intervention

Device:
• Glass Liner
restoration of root caries according to two different protocols

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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