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Clinical Trials/NCT07330089
NCT07330089RecruitingNot Applicable

Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth, a Non Randomized Clinical Study

Foundation University Islamabad1 site in 1 country420 target enrollmentStarted: December 27, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
420
Locations
1
Primary Endpoint
retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study.

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

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)

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.

Outcomes

Primary Outcomes

retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study.

Time Frame: from January 2026 to June 2027

retention of pit and fissure sealants will be accessed through simonsen's criteria on non carious (210 teeth) vs initial carious enamel (210 teeth) with 12 month follow-up to guide follow-up strategies.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shoaib Rahim

Associate Professor

Foundation University Islamabad

Study Sites (1)

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