Retention of a Flowable Resin-based Sealant With Two Types of Adhesives

Summary

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.

Conditions

• Caries,Dental
• Pit and Fissure Caries
• Sealant Dental

Interventions

DEVICE

Scotchbond Universal 3M

The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Scotchbond universal 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).

DEVICE

Single Bond 3M

The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Single Bond 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).

Sponsors & Collaborators

• National University of San Marcos, Peru

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

72 Months

Max Age

83 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2022-07-31

Completion

2022-09-30

Countries

• Peru

Study Locations