Hema Free Versus Hema Containing Adhesives in Posterior Restorations
Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial
1 other identifier
interventional
64
1 country
1
Brief Summary
The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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 14, 2023
CompletedFirst Submitted
Initial submission to the registry
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 25, 2024
September 1, 2024
1.3 years
August 25, 2023
September 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
marginal staining of restoration
marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin
baseline ,6 months & 12 months
Secondary Outcomes (2)
caries recurrence
baseline ,6 months ,12 months
marginal adaptation of restoration
baseline ,6 months and 12 months
Study Arms (2)
HEMA free universal adhesive group
EXPERIMENTALHEMA containing universal adhesive group
ACTIVE COMPARATORInterventions
HEMA free universal adhesive
HEMA containing universal bond
Eligibility Criteria
You may qualify if:
- Patients with occlusal 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 tempromandibular joint disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry Cairo university
Cairo, Manyal, 11555, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of conservative dentistry
Study Record Dates
First Submitted
August 25, 2023
First Posted
September 25, 2024
Study Start
July 14, 2023
Primary Completion
October 14, 2024
Study Completion
November 1, 2024
Last Updated
September 25, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share