NCT07131358 Comparison of the Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Schoolchildren
| NCT ID | NCT07131358 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Nacional Autonoma de Mexico |
| Condition | Caries Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2025-09-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07131358 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 8 Years, studying Caries Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07131358 currently recruiting?
Yes, NCT07131358 is actively recruiting participants. Contact the research team at aborges@unam.mx for enrollment information.
Where is the NCT07131358 trial being conducted?
This trial is being conducted at Nezahualcóyotl, Mexico, Nezahualcóyotl, Mexico, Nezahualcóyotl, Mexico.
Who is sponsoring the NCT07131358 clinical trial?
NCT07131358 is sponsored by Universidad Nacional Autonoma de Mexico. The trial plans to enroll 204 participants.