NIPH Clinical Trials Search

Retention rate and caries preventive effect of new sealant material

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Health Condition
Date of first enrollment	31/10/2025
Target sample size	70
Countries of recruitment
Study type	Interventional
Intervention(s)	For research purposes, different sealant materials (test device: Bondfill SB2, control device: Teethmate F-1 2.0) will be used to seal pits and fissures to prevent caries on the left and right teeth in the same patient's mouth, and retention rates and caries prevention effects will be compared.

Outcome(s)

Primary Outcome	Complete retention rate of sealant after 2 years
Secondary Outcome	Partial retention rate of sealant after 2 years Time until partial loss of sealant Time until complete loss of sealant Incidence rate of pit and fissure caries Time until pit and fissure caries occurs

Key inclusion & exclusion criteria

Age minimum	>= 10age old
Age maximum	<= 12age old
Gender	Both
Include criteria	Healthy children who have completed treatment and visit the clinic regularly for caries prevention Children aged 10 to 12 years (Hermann dental age stage IIIB to IIIC) (at the time of enrollment) Children with healthy upper first or second premolars on both sides who have no history of treatment (The control will be the teeth with the same name) Any gender Those who have given written consent to participate in the study from themselves and their legal representative
Exclude criteria	Individuals who are uncooperative with dental treatment Individuals deemed by the attending physician to be unsuitable for inclusion in this study