RecruitingNot Applicable

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

Mexico204 participantsStarted 2025-09-01

Plain-language summary

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.

Who can participate

Age range6 Years – 8 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Schoolchildren between 6 and 8 years of age, of both sexes, with at least one erupted permanent first molar, healthy or with incipient caries (ICDAS codes 1 and 2), attending public primary schools in the State of Mexico located in the municipality of Nezahualcóyotl. * Schoolchildren with a moderate or high risk of tooth decay according to the caries risk assessment. Exclusion Criteria: * Schoolchildren with the presence of incisor-molar hypomineralization or dental fluorosis. * Schoolchildren with the presence of sealants of fissures and fissures or with a history of their placement in any of the first permanent molars. * School children who have a disability that prevents them from performing the oral clinical examination or interview. * Schoolchildren with allergies or suspected allergies to milk protein and its derivatives, methacrylate monomer and/or acetone.

What they're measuring

Incidence of coronal caries lesions

Timeframe: 24 months

Trial details

NCT IDNCT07131358

SponsorUniversidad Nacional Autonoma de Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Aida Borges, PhD

(52) 55 56 22 55 48 aborges@unam.mx