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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330089
Enrollment
420
Registered
2026-01-09
Start date
2025-12-27
Completion date
2027-06-30
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Enamel, Dental Enamel Hypomineralization, Dental Enamel Hypoplasia

Keywords

pit and fissure sealants, pit sealant, fissure sealant

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.

Interventions

None listed

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study.from January 2026 to June 2027retention 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.

Countries

Pakistan

Contacts

CONTACTDr. Shoaib Rahim, FCPS
clinicaltrials.fucd@fui.edu.pk923215097582
CONTACTDr. Fizza Sherazi, BDS
fizzasherazi1998@gmail.com923242169131
PRINCIPAL_INVESTIGATORDr. Fizza Sherazi, BDS

Foundation University Islamabad

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026