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Completed

NCT Number: NCT05969756

Early Treatments for Preventing Occlusal Caries Lesions

Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.

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Key information

Conditions

Caries; Initial Caries,Dental Dental Caries Occlusal Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hue University of Medicine and Pharmacy, Huế, Thừa Thiên Huế Province, Vietnam

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For children:

  • Children presenting with good general health and cooperative behavior.
  • Children having early caries lesions in a permanent molar (first or second).
  • Parents signed informed consent.

For permanent molars:

  • Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. [Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8].
  • Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). [Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9].

Exclusion criteria

For children:

  • Any allergy reported by the parents.
  • Children unable to return for recall visits.

For permanent molars:

  • Teeth with occlusal surfaces completely covered by the gingival tissue.
  • Teeth with hypoplastic defects, restorations, or sealants.

Treatment and study plan

Fluoride varnish

Drug

Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months

Other names: 3M™ Clinpro™ White Varnish

Conventional etch and rinse sealant

Drug

Thirty-eight permanent molars will receive conventional etch and rinse sealant

Other names: 3M™ Clinpro™ Sealant

Self-etch sealant

Drug

Thirty-eight permanent molars will receive self-etch sealant

Other names: S-PRG filler-containing resin sealant, Beautisealant

Primary outcomes

  1. Development of new caries lesion

    Time frame: 3 months

    ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

  2. Development of new caries lesion

    Time frame: 6 months

    ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

  3. Development of new caries lesion

    Time frame: 9 months

    ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

  4. Development of new caries lesion

    Time frame: 12 months

    ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

Secondary outcomes

  1. Sealants retention

    Time frame: 3 months

    Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.

  2. Sealants retention

    Time frame: 6 months

    Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.

  3. Sealants retention

    Time frame: 9 months

    Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.

  4. Sealants retention

    Time frame: 12 months

    Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.

  5. Quality of sealants

    Time frame: 3 months

    Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.

  6. Quality of sealants

    Time frame: 6 months

    Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.

  7. Quality of sealants

    Time frame: 9 months

    Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.

  8. Quality of sealants

    Time frame: 12 months

    Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.

Sponsors and collaborators

Lead sponsor

Hue University of Medicine and Pharmacy

Other

Registry information

Official study title

Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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