Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
All Genders
Healthy Volunteers
NCT07131358

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

Led by Universidad Nacional Autonoma de Mexico · Updated on 2025-09-24

204

Participants Needed

3

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Schoolchildren aged 6 to 8 years, of both sexes, with at least one erupted permanent first molar
  • Attending public primary schools in Nezahualc�f3yotl, State of Mexico
  • Moderate or high risk of tooth decay according to caries risk assessment
Not Eligible

You will not qualify if you...

  • Presence of incisor-molar hypomineralization or dental fluorosis
  • Presence or history of pit and fissure sealants on any first permanent molars
  • Disability preventing oral clinical examination or interview
  • Allergies or suspected allergies to milk protein, methacrylate monomer, or acetone

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Trial Site Locations

Total: 3 locations

1

Primary School "Belisario Dominguez"

Nezahualcóyotl, State of Mexico, Mexico, 57809

Actively Recruiting

2

Primary School "Emiliano Zapata"

Nezahualcóyotl, State of Mexico, Mexico, 57820

Actively Recruiting

3

Primary School "Venustiano Carranza"

Nezahualcóyotl, State of Mexico, Mexico, 57820

Actively Recruiting

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Research Team

A

Aida Borges, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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