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

NCT07131358 | Recruiting

• 1 other identifier: UNAMexico CIE/0606/03/2025
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

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.

Conditions

Caries Prevention

Keywords

coronal caries; prevention; pit and fissure sealant; fluoride varnish

Outcome Measures

Primary Outcomes (1)

• Incidence of coronal caries lesions

  New lesions with caries progression

  24 months

Study Arms (3)

Group conventional pit and fissure sealant (glass ionomer) plus fluoride varnish

EXPERIMENTAL

Participants receive application of glass ionomer pit and fissure sealant plus semestral applications of fluoride varnish to the first permanent molars, and dental health education program.

Device: Glass ionomer pit and fissure sealant plus fluoride varnish

Group pit and fissure sealant with Giomer® technology

EXPERIMENTAL

Participants receive application of pit and fissure sealant with Giomer® technology to the first permanent molars, and dental health education program.

Device: Pit and fissure sealant with Giomer® technology

Group fluoride varnish

ACTIVE COMPARATOR

Participants receive semestral applications of fluoride varnish to the first permanent molars, and dental health education program.

Device: Fluoride varnish

Interventions

Glass ionomer pit and fissure sealant plus fluoride varnish DEVICE

Application of glass ionomer pit and fissure sealant plus fluoride varnish

Group conventional pit and fissure sealant (glass ionomer) plus fluoride varnish

Pit and fissure sealant with Giomer® technology DEVICE

Application of pit and fissure sealant with Giomer® technology

Group pit and fissure sealant with Giomer® technology

Fluoride varnish DEVICE

Biannual application of fluoride varnish

Group fluoride varnish

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (3)

Primary School "Belisario Dominguez"

Nezahualcóyotl, State of Mexico, 57809, Mexico

RECRUITING

Primary School "Emiliano Zapata"

Nezahualcóyotl, State of Mexico, 57820, Mexico

RECRUITING

Primary School "Venustiano Carranza"

Nezahualcóyotl, State of Mexico, 57820, Mexico

RECRUITING

Related Publications (6)

• Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.

  PMID: 26391116 BACKGROUND

• Rashed T, Alkhalefa N, Adam A, AlKheraif A. Pit and Fissure Sealant versus Fluoride Varnish for the Prevention of Dental Caries in School Children: A Systematic Review and Meta-Analysis. Int J Clin Pract. 2022 Sep 20;2022:8635254. doi: 10.1155/2022/8635254. eCollection 2022.

  PMID: 36263239 BACKGROUND

• Kashbour W, Gupta P, Worthington HV, Boyers D. Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2020 Nov 4;11(11):CD003067. doi: 10.1002/14651858.CD003067.pub5.

  PMID: 33142363 BACKGROUND

• Ng TC, Chu CH, Yu OY. A concise review of dental sealants in caries management. Front Oral Health. 2023 Apr 17;4:1180405. doi: 10.3389/froh.2023.1180405. eCollection 2023.

  PMID: 37138858 BACKGROUND

• Ramamurthy P, Rath A, Sidhu P, Fernandes B, Nettem S, Fee PA, Zaror C, Walsh T. Sealants for preventing dental caries in primary teeth. Cochrane Database Syst Rev. 2022 Feb 11;2(2):CD012981. doi: 10.1002/14651858.CD012981.pub2.

  PMID: 35146744 BACKGROUND

• Ahovuo-Saloranta A, Forss H, Walsh T, Nordblad A, Makela M, Worthington HV. Pit and fissure sealants for preventing dental decay in permanent teeth. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD001830. doi: 10.1002/14651858.CD001830.pub5.

  PMID: 28759120 BACKGROUND

MeSH Terms

Conditions

Van der Woude syndrome

Central Study Contacts

Aida Borges, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aida Borges-Yañez, PhD

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)