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Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hypochlorite, Wizard | Active Comparator | There are many studies in the literature showing that the use of 5.25% NaOCl as an enamel deproteinization agent is successful in positively affecting adhesion by removing organic elements from both the enamel structure and the pellicle on the enamel surface before acid application. However, sodium hypochlorite is a strong oxidizing agent and has disadvantages such as the risk of reaction in the soft tissues of the mouth, bad odor and bad taste, especially if not used carefully in pediatric dentistry, which has led to the search for an alternative material. |
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| Hypochlorous Acid, Superox | Experimental | Hypochlorous acid is produced by the body's immune system cells, neutrophilic polymorphonuclear leukocytes, as a result of oxidative reactions to overcome pathogenic microorganisms and fight infection. Recently, slightly acidic HOCl solutions, developed by electrolysis of NaOCl, have been widely used as disinfectants. Hypochlorous acid has been shown to significantly reduce the lipopolysaccharide concentration of Porphyromonas gingivalis compared to NaOCl and chlorhexidine and to be an agent tolerated by oral tissues. It has also been reported that HOCl used as a mouthwash does not produce any systemic side effects. In clinical dentistry, HOCl has been shown to be highly effective as a result of its antimicrobial and deproteinizing properties. HOCl, with its low acidity, is an antiseptic irrigant with extraordinary properties, not only exhibiting biocompatibility and low cytotoxicity, but also having rapid and highly effective antimicrobial activity in physiological concentration rang |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| application of deproteinization agents | Other | Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Simonsen Criteria | Modified Simonsen Criteria Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries. | Following the sealant application, controls will be made at 6, 12, 24 and 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Edge Integrity Evaluation Criteria | Edge Integrity Evaluation Criteria 0 The fissure sealant and tooth surface are intact and cannot be distinguished with a probe.
| Following the sealant application, controls will be made at 6, 12, 24 and 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Coloration Evaluation Criteria | Marginal Coloration Evaluation Criteria 0 No color change between fissure sealant and tooth.
| Following the sealant application, checks will be made at 6, 12, 24 and 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alem Coşgun | Contact | +905524133222 | alemcosgun@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokat Gaziosmanpaşa University | Recruiting | Tokat Province | 60030 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11145354 | Result | Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601. | |
| 1835987 | Result | Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2023 | May 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2023 | May 16, 2025 | ICF_001.pdf |
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| Anatomical Form Evaluation Criteria |
Anatomical Form Evaluation Criteria 0 Consistent with and continuous with occlusal form and structure.
2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins |
| Following the sealant application, checks will be made at 6, 12, 24 and 36 months |