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The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.
Reducing the incidence of recurrent caries is the primary outcome
Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicta | Experimental | based on dual cure bulk fill bioactive restoration |
|
| Activa presto | Experimental | based on Bio-glass reinforced glass Ionomer |
|
| Giomer | Active Comparator | based on Pre-reacted glass ionomer (PRG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giomer | Device | based on Pre-reacted glass ionomer (PRG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical performance (Post operative hyper sensitivity) | method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present . | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity) | method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha ,Bravo, Charlie) as unite of measurement by scoring %. Alpha is best outcome and Charlie worse outcome. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf Nasr, professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Cairo University, Cairo, Egypt | Cairo | Egypt |
all collected IPD will be shared with supervisor: dr.Ashraf Nasr , Dr. yahia Hafez
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2024 | Dec 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2024 | Dec 12, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2024 | Dec 12, 2024 | ICF_002.pdf |
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parallel assignment
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Double ( participant, Outcome Assessor)