- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06226389
Clinical Evaluation of Different Bulk-fill Composite Restorations on Posterior Teeth (2-Year)
April 27, 2026 updated by: Mansoura University
2-Year Clinical Evaluation of Different Bulk-fill Resin Composite Restorative Systems in Posterior Teeth
Different bulk-fill composites will be applied in different posterior cavities then compared
Study Overview
Status
Completed
Conditions
Detailed Description
Patients must be in middle age(25-55) age,able to regularly follow up,not pregnant and at least have 4 carious molars
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Al Mansurah, Egypt, 35516
- Mansoura,Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- at least 4 carious molars
Exclusion Criteria:
- pregnancy patient
- Not able to regularly follow up
- bad oral hygiene
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1:flowable Bulk-fill composite
Posterior cavities restored using a flowable bulk-fill resin composite placed in a single increment according to the manufacturer's instruction
|
Flowable bulk-fill resin composite material used for posterior restorations
|
|
Experimental: Preheated bulk-fill composite
Posterior cavities restored using a preheated bulk-fill resin composite placed in a single increment according to the manufacturer's instruction
|
preheated bulk-fill resin composite material used for posterior restorations
|
|
Experimental: sonic activated bulk-fill composite
Posterior cavities restored using a sonic bulk-fill resin composite placed in a single increment according to the manufacturer's instruction
|
sonic bulk-fill resin composite material used for posterior restorations
|
|
Experimental: conventional bulk-fill composite
Posterior cavities restored using a conventional bulk-fill resin composite placed in a single increment according to the manufacturer's instruction
|
conventional bulk-fill resin composite material used for posterior restorations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference between baseline and after 2 years of evaluation of resin based composite
Time Frame: Baseline to 2 years
|
Change in FDI criteria
|
Baseline to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asmaa S Elsaeed, Assistant lecturer, Assistant Lecturer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
January 17, 2024
First Submitted That Met QC Criteria
January 17, 2024
First Posted (Actual)
January 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A02011023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Yes Study Protocol, Statistical Analysis Plan can be shared to other researchers
IPD Sharing Time Frame
Data will be available after 2 years
IPD Sharing Access Criteria
For anyone
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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