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Evaluating the effectiveness of caries lesion arrest by pit and fissure sealant based on ICDAS-CAA criteria: A multicenter, prospective, randomized controlled, clinical trial

Evaluating the effectiveness of caries lesion arrest by pit and fissure sealant based on ICDAS-CAA criteria: A multicenter, prospective, randomized controlled, clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084200
Enrollment
Unknown
Registered
2024-05-12
Start date
2024-05-18
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Caries

Interventions

experimental group:Participants in the experimental group receive pit and fissure sealants treatment. Resin-based sealant clinical procedure: The surface of teeth is cleaned with a NSK low-speed motor
controlled group:Participants in the experimental group receive resin composite restoration treatment. Flowable resin composite clinical procedure: The caries tissue is removed with a small round bur

Sponsors

Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 9 Years

Inclusion criteria

Inclusion criteria: The following inclusion criteria are applied: children studying in grades 2; being systemically healthy; having at least one active ICDAS 3 lesion on the pit and fissure of the first permanent molar; radiolucency limited to the outer 1/3 of dentine; deep fissure, not able to see the base of fissure and reached by the tip of a WHO-type periodontal probe; suitable for participating a 2-year clinical trial; able to comply with the clinical trial.

Exclusion criteria

Exclusion criteria: The following exclusion criteria are applied: under medication, known or suspected to be allergic to the materials used in our study; being not suitable for participating (e.g., mouth open restriction, laryngeal reflex, poor compliance); children with semi-erupted first permanent molar, with enamel defects (hypoplasia, hypocalcifications, fluorosis).

Design outcomes

Primary

MeasureTime frame
ICDAS code;

Secondary

MeasureTime frame
retention rate;

Countries

China

Contacts

Public ContactYan Zhou

Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, China

zhouy75@mail.sysu.edu.cn+86 136 3149 7060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026