Caries,Dental Clinical Trial
Official title:
Evaluation of the Retention of a Flowable Resin-based Sealant With Two Types of Adhesives in First Permanent Molars. A Randomized Clinical Trial in 12 Months
The aim of the present study is to compare the use of two adhesives for the placement of occlusal sealants, evaluating their retention on the occlusal surfaces. Methods: A randomized clinical trial, in Phase IV, triple-blind, with a split mouth study design will be adopted, which consists of a simple division of the mouth into two parts (right and left) for the first four permanent molars of each patient, where the placement of the materials will be on the right / left side of the mouth and contralateral. They will then be randomly assigned following block randomization procedures with a 1: 1 allocation. 50 participants (6-year-old children) will be considered, and a pair of permanent first molars homologs will be used for each participant. Inclusion criteria include: children whose parents accepted their participation in the study and who signed the Informed Consent, children enrolled in the Pichanaki District school, children who present upper and / or lower permanent molars with absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II, Green and Vermillion Simplified Oral Hygiene Index of 1-2, have a pair of non-cavitated caries-free counterparts, and children with positive behavior. After selection of patients, the dental sealants will be placed with two different adhesives: the 8th generation adhesive intervention group (Scotchbond universal 3M) and the 5th generation adhesive control group (Single bond 3M), both sealants will use the same flowable resin (Tetric N-flow ivoclar vivadent). Results evaluation: Retention of the sealants will be evaluated at 6, 9 and 12 months. Retention rates of pit and fissure sealant materials will be analyzed according to the split mouth design. The study will use the Mc Nemar test to compare the retention of sealants in the intervention group and the control group at 6, 9 and 12 months. A 95% confidence level will be accepted. In addition, the Cochrane Q test will be applied to determine if there are significant differences in survival for each group of sealants through the evaluation time. The calculation of the survival months of the sealants will be carried out using the actuarial method (survival tables). Expected conclusion: To identify which of the two adhesives presents the best retention after 12 months.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 72 Months to 83 Months |
Eligibility | Inclusion Criteria: - Children whose parents accepted their participation in the study and who signed the Informed Consent - Children enrolled in the Pichanaki District school, Chanchamayo province, in Junin department 6-year-old children, who present upper and / or lower permanent molars with the following characteristics: - Absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II - Green and Vermillion Simplified Oral Hygiene Index (OHI) of 1-2 - Have a pair of non-cavitated caries-free counterparts. - Children with positive behavior. Exclusion Criteria: - Children with the presence of a deep dental caries lesion, with pulp exposure, history of pain and presence of fistula or abscess adjacent to decayed tooth. • Medically compromised children - Children with developmental enamel defects. - Children with a known allergy to any of the resins used - Children with previously placed sealants or restorations - Children residing outside the city |
Country | Name | City | State |
---|---|---|---|
Peru | Nido 380 | Alto Pichanaki | Chanchamayo |
Lead Sponsor | Collaborator |
---|---|
National University of San Marcos, Peru |
Peru,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Retention of adhesives | Determine which of the two adhesives has better clinical retention during the period of 12 months, one with Scotchbond Universal 3M adhesive and the other with Single bond 3M adhesive. | 12 months | |
Secondary | Clinical preservation of sealats | Evaluate the clinical preservation of one sealant with Scotchbond Universal 3M adhesive and another sealant with Single Bond 3M adhesive, in first permanent molars, in the period of 12 months. | 12 months | |
Secondary | .Survival curve of sealants | Estimate the survival curve of one sealant with Scotchbond Universal 3M adhesive and another sealant with Single Bond 3M adhesive, in first permanent molars, in the period of 12 months. | 12 months | |
Secondary | Survivability of sealant | Compare the survivability of a sealant with Scotchbond Universal 3M adhesive and another sealant with Single Bond 3M adhesive, in first permanent molars, in the period of 12 months | 12 months |
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