Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch\&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch\&rinse, SB (Control): Single Bond2+etch\&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 23, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedSeptember 14, 2021
September 1, 2021
4 months
December 23, 2017
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performances of different adhesives
Two year examinations according to USPHS criteria
Two years
Study Arms (7)
Gluma Universal, self-etch mode (GSE)
EXPERIMENTALGluma Universal, selective etching (GSL)
EXPERIMENTALGluma Universal, etch&rinse (GER)
EXPERIMENTALAll Bond Universal, self-etch (ASE)
EXPERIMENTALAll Bond Universal, selective etching (ASL)
EXPERIMENTALAll Bond Universal, etch&rinse (AER)
EXPERIMENTALSingle Bond2, etch&rinse (SBU)
EXPERIMENTALInterventions
Adhesive systems
Adhesive systems
Eligibility Criteria
You may qualify if:
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 7 tooth with NCCLs (d) having antagonist teeth.
You may not qualify if:
- Exlusion criteria will be:
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2017
First Posted
January 30, 2018
Study Start
July 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2018
Last Updated
September 14, 2021
Record last verified: 2021-09