Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars
NCT ID: NCT06235489
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2022-06-01
2024-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars
NCT06166160
Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars
NCT06000085
Comparison Between Sonic Fill and X-tra Fill in Clinical Performance
NCT04926883
Clinical Evaluation of Different Resin Composite Restorations
NCT05418400
Clinical Evaluation of Self- Adhesive Bulk-fill Resin Composite Versus Conventionally Bonded Bulk-fill Resin Composite in Restoration of Proximal Lesions
NCT04888676
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
3. Each patient will be assigned to one of the two groups.
* Group I (n= 59): Plafique Bulk Flow Composite.
* Group II (n=59): EQUIA Forte Group.
4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
5. Matrix is placed and secured in position.
6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
9. They will be given manual tooth brushes and tooth pastes to use during the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palfique Bulk Flow bulk-fil flowable restorative material
Procedure: restoration of proximal cavities of primary molars with bulk-fil flowable composite removal of proximal caries of primary molars and restoration of the cavities prepared by Palfique bulk flow
Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials
Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement
Procedure: Restoration of proximal cavities of primary molars with highly viscous glass ionomer cement removal of proximal caries of primary molars and restoration of the cavities prepared by the Equia forte HT
Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
* Presence of deep bite or any type of malocclusion or parafunctional habits.
* Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).
Exclusion Criteria
* Presence of deep bite or any type of malocclusion or parafunctional habits.
4 Years
8 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mariam Mohamed Abdel Azim
Assistant lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mariem O Wassel, Prof
Role: STUDY_DIRECTOR
Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry, Ain Shams University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PED 22-5D
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.