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The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.
Study Settings:
The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.
Recruitment:
Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.
Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
Materials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer).
Control group:
In the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.
Intervention Group:
In the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.
Outcome Assessment:
The results of sealant retention were assessed according to the following criteria (Simonsen):
A complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Giomer pit and fissure sealant without etching | Active Comparator | In the control group, an adequate amount of primer is applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant is applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions. |
|
| Giomer pit and fissure sealant with etching | Experimental | In the intervention group, the same steps are done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giomer pit and fissure sealant without etching | Drug | S-PRG filler containig pit and fissure sealant without etching step |
|
| Measure | Description | Time Frame |
|---|---|---|
| retention rate | To assess the sealant retention rate either total retention, partial loss or total loss | 3 months, 6months , 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cairo | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, cairo university | Cairo | 11555 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39511504 | Derived | Elmokanen MA, Gad HMA. Retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching: a randomized clinical trial. BMC Oral Health. 2024 Nov 7;24(1):1356. doi: 10.1186/s12903-024-05096-7. |
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| ID | Term |
|---|---|
| D010895 | Pit and Fissure Sealants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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randomized clinical trial
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| Giomer pit and fissure sealant with etching | Drug | S-PRG filler containig pit and fissure sealant with etching step |
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