Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth

Foundation University Islamabad

Status: Not yet enrolling

Conditions: Dental Enamel; Dental Enamel Hypoplasia; Dental Enamel Hypomineralization

Study type: Observational

Funder types: Other

Identifiers

NCT07330089

FUCDOP2512

Details and patient eligibility

About

This clinical study is planned to be conducted to compare retention rates of pits and fissure sealants on non carious (ICDAS score 0) vs Initial carious enamel lesions (ICDAS Score 1,2) in posterior permeant teeth at 3 months, 6 months and 12 months follow-up. This will help us guide follow-up strategies for optimal caries prevention.

Full description

It is an observational, non randomized quasi experimental study design in which patients aged between 7 to 18years will be selected for the study. After obtaining informed consent, the 1st permanent molars and 2nd permanent molar (if erupted) will be evaluated for carious ICDAS SCORE. On the basis of score, the participants will be divided into two groups i.e. non carious group and initial carious group. sample size of 210 teeth will be allocated in each group. Irrespective of the carious status either non carious or initial caries enamel lesions, tooth surfaces will be etched with 37% phosphoric acid (total etch Ivoclar Vivadent) for 15 seconds till frosty white appearance is achieved. the molars will then be sealed by Conseal F sealant and light cured for 20 seconds. The patients will then be called on follow-up at 3, 6 and 12 months and retention of the sealants will be checked using Simonson criteria with the help of explorer. Simonson score I - Completely retained sealants, score II- partially retained sealants , score III complete loss of sealants. All this information will be added in the clinical Performa. After this data collection , data will be analyzed using SPSS 26.0. to compare the proportion of sealants that were lost will be compared using chi square test and p value of 0.05 will be considered significant.

Enrollment: 420 estimated patients

Sex: All

Ages: 7 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fully erupted maxillary and mandibular 1st and 2nd molars with antagonist teeth present.
• ICDAS score 0,I,II
• Age 7 to 18 years
• Both genders included

Exclusion criteria

• permanent teeth requiring restorations,
• uncooperative patients
• patients unwilling for follow-ups
• molars withy antagonist teeth not present
• mentally and physically handicapped patients
• patients with parafunctional habits
• patients undergoing orthodontic treatments

Trial design

420 participants in 2 patient groups

Group 1: pit and fissure sealant non carious enamel lesions (ICDAS score 0)

Description:

pits and fissure sealants will be applied in non carious (sound) enamel surfaces of posterior permanent teeth and the retention will the evaluated at 3, 6 , and 12 months.

Group 2: pit and fissure sealant on Initial caries enamel lesions (ICDAS I and II)

Description:

pits and fissure sealants will be applied in initial carious enamel surfaces of posterior permanent teeth and the retention will the evaluated at 3, 6 , and 12 months.