Clinical Evaluation of Bioactive Injectable Resin Composite in Posterior Restorations
1 other identifier
interventional
26
1 country
1
Brief Summary
The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
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
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 11, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedAugust 15, 2022
August 1, 2022
1.5 years
August 11, 2022
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the clinical performance
Measured using modified USPHS criteria
From baseline to 18 months
Study Arms (2)
injectable composite
EXPERIMENTALThe material will be applied according to manufacturer instructions. BEAUTIFIL Flow Plus X will be applied directly into the cavity and create the shape desired in layers not exceeding 2 mm, and light cured for 20 seconds.
Nanohybrid resin composite
ACTIVE COMPARATORThe nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions.
Interventions
bioactive injectable composite
Eligibility Criteria
You may qualify if:
- Participants:
- Age range 20-50 years.
- Males Or females .
- Co-operative patients approving to participate in the trial.
- Teeth:
- class I or II carious lesions premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
You may not qualify if:
- Participants:
- Patients with general systemic illness.
- Allergic history against any component of used material.
- Disabilities.
- Pregnancy
- Xerostomia.
- Lack of compliance.
- Evidence of parafunctional habits.
- Temporomandibular joint disorders.
- Teeth:
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry, Cairo University
Cairo, Egypt
Study Officials
- STUDY DIRECTOR
Mai Mamdouh, PhD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer at operative dentistry
Study Record Dates
First Submitted
August 11, 2022
First Posted
August 12, 2022
Study Start
August 1, 2022
Primary Completion
February 1, 2024
Study Completion
March 1, 2024
Last Updated
August 15, 2022
Record last verified: 2022-08