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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Enamel Hypoplasia; Dental Enamel Hypomineralization; Dental Enamel

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 Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Dr. Shoaib Rahim, FCPS; Phone Number: 923215097582; Email: clinicaltrials.fucd@fui.edu.pk
• Study Contact Backup: Name: Dr. Fizza Sherazi, BDS; Phone Number: 923242169131; Email: fizzasherazi1998@gmail.com

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Recruiting
      • Foundation University Islamabad
      • Contact: Nadia Aman, BDS, FCPS; Phone Number: 00923022526440; Email: nadia.aman@fui.edu.pk
      • Contact: Shoaib Rahim, FCPS; Phone Number: 00923215097582; Email: clinicaltrials.fucd@fui.edu.pk
      • Principal Investigator: Fizza Sherazi, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients reporting to Paedodontics and Operative dentistry department of FUCD&H will be selected according to inclusion criteria after history, clinical examination.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study.	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.	from January 2026 to June 2027

Collaborators and Investigators

• Sponsor: Foundation University Islamabad
• Investigators: Principal Investigator: Dr. Fizza Sherazi, BDS, Foundation University Islamabad

Publications and helpful links

General Publications

• Nair SM, Nene KS, Tirupathi S, Mathur AA, Khan HA, Godbole NM, Patil PP, Deolikar SA. Effect of Enamel Deproteinization Prior to Etching on the Clinical Performance of Resin-based Pit and Fissure Sealants: A Split-mouth Double-blinded Pilot Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Feb;18(2):119-125. doi: 10.5005/jp-journals-10005-3051. Epub 2025 Mar 20.
• 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.
• Demineralization and remineralization dynamics and dental caries.
• Evaluating the effectiveness of dental sealants in caries prevention and tooth protection
• 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.
• Microscopic evaluation of fissure patterns of posterior permanent teeth: An in vitro study
• Pit and Fissure Sealants as a Viable Preventive Tool for Dental Caries
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pit and fissure sealants; fissure sealant; pit sealant
• Additional Relevant MeSH Terms: Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dental Enamel Hypomineralization; Dental Enamel Hypoplasia; Van der Woude syndrome
• Other Study ID Numbers: FUCDOP2512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. literature review
   Information comments: esearchgate.net/publication/377562421_Pit_and_Fissure_Sealants_as_a_Viable_Preventive_Tool_for_Dental_Caries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No