Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Shorter than P25 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
First Submitted
Initial submission to the registry
February 2, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJune 2, 2022
May 1, 2022
Same day
February 2, 2022
May 29, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Clinical performance
Postoperative Hypersensitivity Secondary caries
Change from the baseline at 6 months and at 12 months.
Clinical performance
Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Clinical performance
Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Clinical performance
Color match and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Clinical performance
Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Clinical performance
Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Clinical performance
Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)
Change from the baseline at 6 months and at 12 months.
Secondary Outcomes (1)
Wear resistance evaluation
Change from the baseline at 6 months and at 12 months.
Study Arms (2)
Zirconomer improved
OTHERa nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.
Nano hybird resin composite
ACTIVE COMPARATORResin composite (RC) is the gold standard esthetic restoration in proximal cavities due to their high aesthetic properties, increased mechanical durability and enhanced adhesion to tooth structure.
Interventions
Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.
Eligibility Criteria
You may qualify if:
- Age group 18-55
- Presence of occluding tooth.
- Good oral hygiene
You may not qualify if:
- Poor periodontal status
- Adverse medical history.
- Potential behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed El-Hoshy, Professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Assessors and statistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree student, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Study Record Dates
First Submitted
February 2, 2022
First Posted
June 2, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2022
Study Completion
February 1, 2023
Last Updated
June 2, 2022
Record last verified: 2022-05