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Clinical performance of resin-based sealant with universal adhesive system on initial carious lesions of permanent molars: A Split-Mouth Randomized Clinical Trial

Clinical performance of resin-based sealant with universal adhesive system on initial carious lesions of permanent molars: A Split-Mouth Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250924006
Enrollment
540
Registered
2025-09-24
Start date
2025-09-03
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Initial carious lesions of permanent molars in children between 6-8 years old Children Pit and Fissure Sealant Dentin-Bonding Agent Dental adhesive Permanent molar Initial caries

Interventions

Resin-based sealant( Sealant, 3M ESPE, USA) is applied to all surface areas using the syringe needle tip and cured for 20 seconds with an LED light curing unit.,Dental adhesive (Single Bond Universal
Control,Cured adhesive technique,Uncured adhesive technique

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
6 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Healthy children aged 6-8 years 2. Children with fully erupted bilateral first permanent molars in either the maxillary or mandibular arch, presenting deep pits and fissures with initial carious lesions classified as ICDAS II codes 1-3. 3. Parents or legal guardians provide written informed consent for participation.

Exclusion criteria

Exclusion criteria: 1. Children who are uncooperative during procedures. 2. Permanent molars presenting with enamel developmental defects. 3. Permanent molars that have been restored and/or sealed with pit and fissure sealants. 4. Permanent molars with clinically detectable proximal carious lesions.

Design outcomes

Primary

MeasureTime frame
Retention Immediately after placement, 6, 12, 18, 24, 30 months, and 36 months post-treatment Retention rate

Secondary

MeasureTime frame
Present or absent new caries formation Immediately after placement, 6, 12, 18, 24, 30 months, and 36 months post-treatment New caries formation

Countries

Thailand

Contacts

Public ContactVarangkanar Jirarattanasopha

Faculty of Dentistry, Mahidol University

varangkanar.jir@mahhidol.ac.th660817522571

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026