Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions
Primary Purpose
Secondary Dental Caries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Predicta Bioactive bulk fil composite restoration
Sponsored by
About this trial
This is an interventional other trial for Secondary Dental Caries
Eligibility Criteria
Inclusion Criteria:
Patient inclusion:
- Patients Scheduled for head and neck radiotherapy.
- age: ≥18 years.
- Patients with good likelihood of recall availability.
Tooth inclusion:
- Permanent premolars or molars.
- Primary occlusal carious lesions.
- Vital with positive reaction to cold thermal stimulus.
- Well-formed and fully-erupted.
Exclusion Criteria:Patient exclusion:
- Participants with late stage head and neck cancer
- Concomitant participation in another research study.
- Inability to comply with study procedures
- past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
N 2-Non-vital teeth. 3-Secondary carious lesions
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Predicta Bioactive bulk fil composite restoration
High viscosity glass ionomer (Equia Fil)
Arm Description
Bioactive bulk fil resin composite dental restoration material
High viscosity dental restoration material
Outcomes
Primary Outcome Measures
Secondary caries
biological outcome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05332041
Brief Title
Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions
Official Title
Clinical Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Restoring Occlusal Carious Lesions of Posterior Teeth in Patients Scheduled for Head and Neck Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy.
Detailed Description
Inspite of recent developments in the materials' science, some novel materials require direct association with components of the oral cavity for renewal or recharging of the constituents of the restoration to enhance marginal integrity and thus decrease bacterial microleakage, marginal discoloration and postoperative hypersensitivity . There is a constant increase in aesthetic demand for a material that ensures near to perfect adhesion to the tooth surface in order to minimize microleakage and improve marginal integrity. Microleakage forms the basis for predicting the performance of any restorative material Bioactive restorative materials have been introduced for numerous utilizations in dentistry. Among these are fluorides for remineralization; antibacterial resins and restoratives that release and recharge fluorides, phosphate and hydroxyle ions and thus can enhance marginal integrity . Bioactive restorative materials are reported to release more fluoride than glass ionomers. Additionally, they react to pH changes in the mouth by uptaking calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure.
It is proposed that contemporary bioactive esthetic materials, which associate with oral fluids and show recharge and renewal of restorative material constituents, have the potential to reduce bacterial microleakage and enhance marginal integrity, One possible approach to increase the resistance of restorations to secondary caries formation is to use bioactive materials ( Like predicta bilk fil composite) that contain agents which negatively influence the micro-organisms and/or promote remineralization of tooth structure.
High viscosity glass ionomer (EQUIA Fil) has new technology that contains ultrafine and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Dental Caries
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Predicta Bioactive bulk fil composite restoration
Arm Type
Experimental
Arm Description
Bioactive bulk fil resin composite dental restoration material
Arm Title
High viscosity glass ionomer (Equia Fil)
Arm Type
Active Comparator
Arm Description
High viscosity dental restoration material
Intervention Type
Other
Intervention Name(s)
Predicta Bioactive bulk fil composite restoration
Intervention Description
Predicta Bioactive bulk fil resin composite restoration material
Primary Outcome Measure Information:
Title
Secondary caries
Description
biological outcome
Time Frame
one year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient inclusion:
Patients Scheduled for head and neck radiotherapy.
age: ≥18 years.
Patients with good likelihood of recall availability.
Tooth inclusion:
Permanent premolars or molars.
Primary occlusal carious lesions.
Vital with positive reaction to cold thermal stimulus.
Well-formed and fully-erupted.
Exclusion Criteria:Patient exclusion:
Participants with late stage head and neck cancer
Concomitant participation in another research study.
Inability to comply with study procedures
past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
N 2-Non-vital teeth. 3-Secondary carious lesions
-
12. IPD Sharing Statement
Learn more about this trial
Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions
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