Contact Tightness of Zirconomer Versus Nanohybrid Composite in Occlusoproximal Cavities in Molars
Comparison of Proximal Contact Tightness of Zirconia Reinforced Glass Ionomer Versus Conventional Nanohybrid Resin Composite: a Randomized Clinical Trial
1 other identifier
interventional
52
1 country
1
Brief Summary
To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II 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 Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2023
CompletedFirst Submitted
Initial submission to the registry
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 19, 2024
September 1, 2024
1.2 years
August 25, 2023
September 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contact Tightness
Measuring the adequacy of proximal contact restoration using intervention \' zirconomer\" versus control which is Nanohybrid resin composite. Heaviness of this contact using Modified USPHS criteria. USPHS criteria are standardized in which a dental floss is used. Contact tightness can have one of three scores: Alpha Bravo Charlie
baseline, 3 months, 6 months, 9 months and 1 year
Study Arms (2)
Zirconomer in Class II cavities
EXPERIMENTALZirconia modified glass ionomer restorative material
Nanohybrid composite in Class II cavities
ACTIVE COMPARATORConventionally used aesthetic restorations in class II
Interventions
Eligibility Criteria
You may qualify if:
- Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
- years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
You may not qualify if:
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
- Heavy smoking.
- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders.
- b- Eligibility Criteria of teeth:
- Occlusoproximal caries in molars classified as ICDAS III or IV.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Intact contact with opposing teeth.
- Teeth with no previous restorations in other surfaces.
- Extensive carious lesions
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry Cairo university
Cairo, Manyal, 11555, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa F Abdelsalam, phD
lecturer of conservative dentistry, Cairo university
- PRINCIPAL INVESTIGATOR
Hadier M Gad, PhD
Lecturer of conservative dentistry, Cairo university
- PRINCIPAL INVESTIGATOR
Manar A Elmokanen, PhD
Lecturer of conservative dentistry, Cairo University
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 in investigator
Study Record Dates
First Submitted
August 25, 2023
First Posted
September 19, 2024
Study Start
July 12, 2023
Primary Completion
September 12, 2024
Study Completion
November 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share