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

NCT07330089 | Not Yet Recruiting

• 1 other identifier: FUCDOP2512
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Enamel; Dental Enamel Hypoplasia; Dental Enamel Hypomineralization

Keywords

pit and fissure sealants; pit sealant; fissure sealant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Related Publications (9)

• 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.

  PMID: 40417445 BACKGROUND

• 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.

  PMID: 39672849 BACKGROUND

• Demineralization and remineralization dynamics and dental caries.

  BACKGROUND

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

  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.

  PMID: 33037372 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 36141263 BACKGROUND

• 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.

  PMID: 39543891 BACKGROUND

MeSH Terms

Conditions

Dental Enamel Hypomineralization; Dental Enamel Hypoplasia; Van der Woude syndrome

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dr. Fizza Sherazi, BDS

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shoaib Rahim, FCPS

CONTACT

923215097582; clinicaltrials.fucd@fui.edu.pk

Dr. Fizza Sherazi, BDS

CONTACT

923242169131; fizzasherazi1998@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: December 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01