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NCT Number: NCT07330089

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

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.

Recruiting

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Fizza Sherazi, BDS

CONTACT

[email protected]

923242169131

Dr. Shoaib Rahim, FCPS

CONTACT

[email protected]

923215097582

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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