5-year Clinical Evaluation of Cavity Lining on the Restoration
Primary Purpose
Teeth; Lesion, Dental Root Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass Liner
Sponsored by
About this trial
This is an interventional treatment trial for Teeth; Lesion focused on measuring Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Glass Liner
No liner
Arm Description
Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03802539
Brief Title
5-year Clinical Evaluation of Cavity Lining on the Restoration
Official Title
5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth; Lesion, Dental Root Caries
Keywords
Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glass Liner
Arm Type
Experimental
Arm Description
Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
Arm Title
No liner
Arm Type
No Intervention
Arm Description
Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin
Intervention Type
Device
Intervention Name(s)
Glass Liner
Intervention Description
restoration of root caries according to two different protocols
Primary Outcome Measure Information:
Title
Retention Outcome
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
31273529
Citation
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.
Results Reference
derived
Learn more about this trial
5-year Clinical Evaluation of Cavity Lining on the Restoration
We'll reach out to this number within 24 hrs