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

NCT ID: NCT07330089

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-27
• Study Completion Date: 2027-06-30

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.

Conditions

Dental Enamel; Dental Enamel Hypomineralization; Dental Enamel Hypoplasia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Shoaib Rahim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Fizza Sherazi, BDS

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Central Contacts

Dr. Shoaib Rahim, FCPS

Role: CONTACT

clinicaltrials.fucd@fui.edu.pk

923215097582

Dr. Fizza Sherazi, BDS

Role: CONTACT

fizzasherazi1998@gmail.com

923242169131

References

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Reference Type: BACKGROUND

PMID: 12099072 (View on PubMed)

McKenna G. A clinical guide to advanced minimum intervention restorative dentistry (1st ed). Br Dent J. 2024 Dec;237(11):834. doi: 10.1038/s41415-024-8183-0. No abstract available.

Reference Type: BACKGROUND

PMID: 39672849 (View on PubMed)

Demineralization and remineralization dynamics and dental caries.

Reference Type: BACKGROUND

Evaluating the effectiveness of dental sealants in caries prevention and tooth protection

Reference Type: BACKGROUND

Banerjee A, Splieth C, Breschi L, Fontana M, Paris S, Burrow M, Crombie F, Foster Page L, Gaton-Hernandez P, Giacaman RA, Gugnani N, Hickel R, A Jordan R, Leal S, Lo E, Tassery H, Thomson WM, Manton DJ, Schwendicke F. When to intervene in the caries process? A Delphi consensus statement. Br Dent J. 2020 Oct;229(7):474-482. doi: 10.1038/s41415-020-2220-4.

Reference Type: BACKGROUND

PMID: 33037372 (View on PubMed)

Microscopic evaluation of fissure patterns of posterior permanent teeth: An in vitro study

Reference Type: BACKGROUND

Pit and Fissure Sealants as a Viable Preventive Tool for Dental Caries

Reference Type: BACKGROUND

Beresescu L, Pacurar M, Bica CI, Vlasa A, Stoica OE, Dako T, Petcu B, Esian D. The Assessment of Sealants' Effectiveness in Arresting Non-Cavitated Caries Lesion-A 24-Month Follow-Up. Healthcare (Basel). 2022 Aug 30;10(9):1651. doi: 10.3390/healthcare10091651.

Reference Type: BACKGROUND

PMID: 36141263 (View on PubMed)

Carrillo Ortiz AE, Olvera Fuentes CA, Garcia Perez A, Rodriguez Chavez JA, Villanueva Gutierrez T, Flores Ruiz HM, Mora Navarrete KA. Prevalence and severity of dental caries using ICDAS in predicting treatment needs in Mexican school-age children. J Clin Pediatr Dent. 2024 Nov;48(6):144-151. doi: 10.22514/jocpd.2024.134. Epub 2024 Nov 3.

Reference Type: BACKGROUND

PMID: 39543891 (View on PubMed)

Study Documents

Document Type: literature review

esearchgate.net/publication/377562421\_Pit\_and\_Fissure\_Sealants\_as\_a\_Viable\_Preventive\_Tool\_for\_Dental\_Caries

View Document

Other Identifiers

FUCDOP2512

Identifier Type: -

Identifier Source: org_study_id