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A Split-Mouth Prospective Clinical Study on the Clinical Performance of Self-Adhering and S-PRG-Containing Fissure Sealants in Erupting Molars

A Split-Mouth Prospective Clinical Study on the Clinical Performance of Self-Adhering and S-PRG-Containing Fissure Sealants in Erupting Molars

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260414001
Enrollment
45
Registered
2026-04-14
Start date
2026-05-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Prevention of occlusal caries in erupting first permanent molars Fissure sealant, Self-adhering, S-PRG, Erupting molar

Interventions

Giomer-based S-PRG fissure sealant will be applied to the occlusal surfaces of the first permanent molars after cleaning and acid etching according to manufacturer instructions,Self-adhering fissure s
Experimental Device,Active Comparator Device
S-PRG-containing fissure sealant,Self-adhering fissure sealant

Sponsors

Ataturk University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: Pediatric patients aged 5-8 years with no sistemic diseases. Having at least two contralateral erupting first permanent molars suitable for split-mouth design. Teeth must be vital and caries-free

Exclusion criteria

Exclusion criteria: 1. Children with systemic diseases or conditions affecting oral health 2. Teeth with extensive occlusal caries, pulpal involvement, restorations, or cracks/fractures 3. Teeth that are non-vital or partially erupted in a way that prevents proper sealant application 4. Children with poor oral hygiene or uncooperative behavior that would interfere with clinical procedures 5. Children whose parents or legal guardians do not provide written informed consent

Design outcomes

Primary

MeasureTime frame
Clinical performance of fissure sealants, Caries development, Marginal integrity 1, 6, and 12 months Retention of sealant, Modified USPHS criteria. Caries development: Clinical visual inspection and intraoral scanning (iTero). Marginal integrity: Evaluated using USPHS criteria.

Secondary

MeasureTime frame
Material-specific wear and surface characteristics 1, 6, and 12 months Assessed using intraoral scanning (iTero) and clinical inspection

Countries

Turkey

Contacts

Public ContactFatih Sengul

Ataturk University

fatihs@gmail.com5326375807

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026