Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
Primary Purpose
Dental Leakage
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Etching
Sponsored by
About this trial
This is an interventional treatment trial for Dental Leakage focused on measuring Resin Composite, Randomized Clinical Trial, Operative Dentistry
Eligibility Criteria
Inclusion Criteria:
- Patients with primary caries involving occlusal surface only with ICDAS 2 and 3.
- Patients with cavities no more than one-third of the intercuspal distance.
- Patients must have a good oral hygiene.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients with normal and full occlusion.
- Patients with opposing teeth should be natural with no restorations.
Exclusion Criteria:
- High caries risk patients with extremely poor oral hygiene.
- Patients involved in orthodontic treatment or periodontal surgery.
- Patients with periodontally involved teeth (chronic periodontitis).
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Etch-and-rinse (Variolink N) resin cement
Self-etch (Panavia F2.0) resin cement
Self-adhesive (RelyX Unicem) resin cement
Arm Description
For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement.
Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement.
For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement.
Outcomes
Primary Outcome Measures
Percentage % of patients with marginal staining
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04848987
Brief Title
Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
Official Title
Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
October 10, 2016 (Actual)
Study Completion Date
September 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?
Detailed Description
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Leakage
Keywords
Resin Composite, Randomized Clinical Trial, Operative Dentistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etch-and-rinse (Variolink N) resin cement
Arm Type
Active Comparator
Arm Description
For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement.
Arm Title
Self-etch (Panavia F2.0) resin cement
Arm Type
Placebo Comparator
Arm Description
Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement.
Arm Title
Self-adhesive (RelyX Unicem) resin cement
Arm Type
No Intervention
Arm Description
For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement.
Intervention Type
Procedure
Intervention Name(s)
Etching
Intervention Description
Etching enamel surface using phosphoric acid
Primary Outcome Measure Information:
Title
Percentage % of patients with marginal staining
Description
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Time Frame
5 years after restoration procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with primary caries involving occlusal surface only with ICDAS 2 and 3.
Patients with cavities no more than one-third of the intercuspal distance.
Patients must have a good oral hygiene.
Patients with tooth gives positive response to testing with an electric pulp tester.
Patients with normal and full occlusion.
Patients with opposing teeth should be natural with no restorations.
Exclusion Criteria:
High caries risk patients with extremely poor oral hygiene.
Patients involved in orthodontic treatment or periodontal surgery.
Patients with periodontally involved teeth (chronic periodontitis).
Patients with abutments should be excluded.
Patients with heavy bruxism habits and clenching.
Facility Information:
Facility Name
Faculty of Dentistry
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
study Protocol, Statistical Analysis Plan can be shared to other researchers
IPD Sharing Time Frame
Data will be available within 3 Months for 5 years
IPD Sharing Access Criteria
For anyone
Learn more about this trial
Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
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