Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients
NCT ID: NCT06736964
Last Updated: 2024-12-17
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
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-10-01
2026-04-01
Brief Summary
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Reducing the incidence of recurrent caries is the primary outcome
Detailed Description
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Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .
This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Predicta
based on dual cure bulk fill bioactive restoration
Giomer
based on Pre-reacted glass ionomer (PRG)
Activa presto
based on Bio-glass reinforced glass Ionomer
Giomer
based on Pre-reacted glass ionomer (PRG)
Giomer
based on Pre-reacted glass ionomer (PRG)
Giomer
based on Pre-reacted glass ionomer (PRG)
Interventions
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Giomer
based on Pre-reacted glass ionomer (PRG)
Eligibility Criteria
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Inclusion Criteria
* High risk caries.
* Patients required at least a couple of Class V restorations.
* The depth of lesion should be(1.5- 2 mm) .
* The patient should have good general health
Exclusion Criteria
* Sever or chronic periodontal disease or Bruxism.
* Severe tooth sensitivity.
* Non-vital or fracture or cracked teeth.
* Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
* pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study
25 Years
45 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Yehia Hafez Yehia
Lecturer of Conservative Dentistry Department
Principal Investigators
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Ashraf Nasr, professor
Role: STUDY_DIRECTOR
Cairo University
Locations
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Faculty of Dentistry Cairo University, Cairo, Egypt
Cairo, , Egypt
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Ahmed abdul monsif
Identifier Type: -
Identifier Source: org_study_id