Efficiency of Different Modes of Universal Adhesive
Primary Purpose
Dental Caries, Adhesion
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Self-etch
Total-etch
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- a need for at least two but not more than four posterior tooth-colored restorations
- the presence of teeth to be restored in occlusion
- teeth that were symptomless and vital
- a normal periodontal status
- a good likelihood of recall availability.
Exclusion Criteria:
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-etch
Total-etch
Arm Description
Self-etch mode of the universal adhesive will be used
Total etch mode of the universal adhesive will be used
Outcomes
Primary Outcome Measures
Marginal adaptation
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation.
Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
Marginal discoloration
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration.
Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Retention
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate.
Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Anatomic form
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form.
Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Color change
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
Secondary Outcome Measures
Full Information
NCT ID
NCT04271150
First Posted
February 12, 2020
Last Updated
February 13, 2020
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT04271150
Brief Title
Efficiency of Different Modes of Universal Adhesive
Official Title
Clinical Evaluation of Universal Adhesive's Different Application Modes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
May 1, 2025 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.
Detailed Description
Class 2 composite restorations will be placed using a bulk-fill composite resin restorative on two posterior teeth with proximal caries, in a split mouth design. 25 patients will be included in the study. The teeth will be randomized into two groups according to the application mode of universal adhesive material.
Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Adhesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-etch
Arm Type
Experimental
Arm Description
Self-etch mode of the universal adhesive will be used
Arm Title
Total-etch
Arm Type
Active Comparator
Arm Description
Total etch mode of the universal adhesive will be used
Intervention Type
Device
Intervention Name(s)
Self-etch
Intervention Description
Universal adhesive with self-etch mode
Intervention Type
Device
Intervention Name(s)
Total-etch
Intervention Description
Universal adhesive with total-etch mode
Primary Outcome Measure Information:
Title
Marginal adaptation
Description
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation.
Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
Time Frame
From baseline to 6 year the change of restorations will be evaluated
Title
Marginal discoloration
Description
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration.
Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Time Frame
From baseline to 6 year the change of restorations will be evaluated
Title
Retention
Description
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate.
Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Time Frame
From baseline to 6 year the change of restorations will be evaluated.
Title
Anatomic form
Description
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form.
Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Time Frame
From baseline to 6 year the change of restorations will be evaluated.
Title
Color change
Description
Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
Time Frame
From baseline to 6 year the change of restorations will be evaluated.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
a need for at least two but not more than four posterior tooth-colored restorations
the presence of teeth to be restored in occlusion
teeth that were symptomless and vital
a normal periodontal status
a good likelihood of recall availability.
Exclusion Criteria:
partly erupted teeth
absence of adjacent and antagonist teeth
poor periodontal status
adverse medical history
potential behavioral problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse R Yazici, DDS, PhD
Organizational Affiliation
Hacettepe University School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28581919
Description
PUBMED
URL
https://www.ncbi.nlm.nih.gov/pubmed/29630489
Description
PUBMED
Learn more about this trial
Efficiency of Different Modes of Universal Adhesive
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