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Recruiting NCT07330089

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

— Observational Dental Enamel Dental Enamel Hypomineralization Dental Enamel Hypoplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dental Enamel, Dental Enamel Hypomineralization, Dental Enamel Hypoplasia. Basic parameters: 7 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Pakistan · 1 center
  • Foundation University Islamabad — Islamabad

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. PMID 40417445
  • 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
  • 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. PMID 33037372
  • 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. PMID 36141263

Identifiers

NCT: NCT07330089 · FUCDOP2512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗