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A randomized controlled trial and cost-utility analysis of pit and fissure sealant programme in first molar in 7-8 years old children in Guangzhou

A randomized controlled trial and cost-utility analysis of pit and fissure sealant programme in first molar in 7-8 years old children in Guangzhou

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029862
Enrollment
Unknown
Registered
2020-02-15
Start date
2020-08-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Dental caries

Interventions

treatment arm:sealing the pit and fissure of the first permanent molar with ICDAS scores of 3
control arm:flowable resin restoration for the first permanent molar with ICDAS scores of 3

Sponsors

Hospital of Stomatology, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1. Second-grade primary school students, male or female; 2. Good general health state; 3. At least having one first permanent molar with an ICDAS score of 3, and is completely erupted. 4. Deep pits and fissures and are completely exposed to the mouth; 5. Be able to participate in clinical research for a period of 24 months, with the ability and willingness to follow the research procedures required by the research protocol.

Exclusion criteria

Exclusion criteria: 1.Using or in need of antibiotics/Chinese herbal medicines during screening; 2. Children who are known or suspected to be allergic or intolerant to the materials or ingredients used; 3. Researchers believe that their general and oral conditions are not suitable for patients participating in this study (such as low grade of open mouth, obvious pharyngeal reflex, poor coordination, etc.); 4. Teeth have enamel hypoplasia, fluorosis, or tetracycline teeth; 5. Abnormal occlusal function, sleep bruxism, or clenching teeth.

Design outcomes

Primary

MeasureTime frame
ICDAS;

Secondary

MeasureTime frame
sealant retention;Demographic information;Oral health behavior information;Cost;Radiographs;

Countries

China

Contacts

Public ContactYan Zhou

Hospital of Stomatology, Sun Yat-Sen University

zhouy75@mail.sysu.edu.cn+86 13631497060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026