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Comparison of the Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Schoolchildren

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 2025 to Sep 1, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this clinical trial is to compare the efficacy of three preventive methods in reducing the incidence of coronal caries in the first permanent molars of Mexican schoolchildren. The main question to be answered is: Which of the preventive methods (application of fluoride varnish (control group), application of a conventional pit and fissure sealant (glass ionomer) plus fluoride varnish, or application of a pit and fissure sealant with Giomer® technology) will be more effective in preventing coronal caries in the first permanent molars of Mexican schoolchildren? Hypothesis: The incidence of coronal caries with the application of a conventional pit and fissure sealant (glass ionomer) plus fluoride varnish will be lower compared to the application of a pit and fissure sealant with Giomer® technology and compared to the application of fluoride varnish (control group). Three groups will be formed (68 participants each): one group will receive the application of sodium fluoride varnish (control group), a second group will receive the application of conventional pit and fissure sealant (glass ionomer) plus sodium fluoride varnish, and a third group will receive the application of pit and fissure sealant with Giomer® technology. All groups will receive dental health education (importance of oral health, information about dental caries, oral hygiene practices, and information about coronal caries prevention). Preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18 and 24 months. The incidence of coronal caries between groups will be compared with the presence of surfaces with progression of caries in the first permanent molars. The best preventive method can be proposed for use in caries prevention programmes in schoolchildren. The results will provide elements for the dental surgeon in decision-making to prevent caries lesions in schoolchildren.
Trial Details
NCT Number NCT07131358
Lead Sponsor Universidad Nacional Autonoma de Mexico
Conditions
(from sponsor)		 Caries Prevention
Related terms Van der Woude syndrome
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov