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Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride varnish group | Experimental | 5% sodium fluoride varnish, 3M, USA |
|
| Conventional etch and rinse sealant group | Experimental | Resin-based composite sealant, 3M, USA |
|
| Self-etch sealant group | Active Comparator | Self-etch primed sealant, Shofu, Japan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnish | Drug | Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of new caries lesion | ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion | 3 months |
| Development of new caries lesion | ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion | 6 months |
| Development of new caries lesion | ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion | 9 months |
| Development of new caries lesion | ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sealants retention | Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface. | 3 months |
| Sealants retention |
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Inclusion Criteria:
For children:
For permanent molars:
Exclusion Criteria:
For children:
For permanent molars:
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| Name | Affiliation | Role |
|---|---|---|
| Van Nhat Thang Le, DDS, PhD | Hue University of Medicine and Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hue University of Medicine and Pharmacy | Huế | Thừa Thiên Huế Province | 49120 | Vietnam | ||
| Phu Vang Hospital |
Will plan to share information when finishing study
Plan to complete study in 1 year and will share the data after get publication
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.
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Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
| Conventional etch and rinse sealant | Drug | Thirty-eight permanent molars will receive conventional etch and rinse sealant |
|
|
| Self-etch sealant | Drug | Thirty-eight permanent molars will receive self-etch sealant |
|
|
Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
| 6 months |
| Sealants retention | Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface. | 9 months |
| Sealants retention | Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface. | 12 months |
| Quality of sealants | Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration. | 3 months |
| Quality of sealants | Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration. | 6 months |
| Quality of sealants | Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration. | 9 months |
| Quality of sealants | Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration. | 12 months |
| Phú Vang |
| Thừa Thiên Huế Province |
| 49900 |
| Vietnam |