Glass Ionomer-Based Fissure Sealants in Children (NCT07388472) | Clinical Trial Compass
CompletedNot Applicable
Glass Ionomer-Based Fissure Sealants in Children
Turkey (Türkiye)200 participantsStarted 2016-11
Plain-language summary
This study aimed to comparatively evaluate the 24-month clinical retention performance and caries-preventive efficacy of three glass ionomer-based fissure sealants with different compositions.
Who can participate
Age range6 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The study comprised 200 healthy children aged between 6 and 12 years, ASA class I (American Society of Anesthesiologists),
* 27 who were determined to exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
* All participants had fully erupted lower first permanent molars on both sides which required the application of pit and fissure sealants.
* The inclusion criteria were based on the International Caries Detection and Assessment System II (ICDAS II) criteria,28 including deep and retained pits and fissures, no restorations, and no evidence of caries lesions.
* The teeth were examined using the caries diagnosis device (DIAGNOdent pen 2190, KaVo, USA); readings of ≤ 15 were included in the study as well.
Exclusion Criteria:
* Participants with special needs or systemic disease (ASA classification II or higher),
* requiring emergency dental care,
* suffering from a severe gag reflex or
* an allergy to latex,
* exhibiting uncooperative behavior (Frankl Score 1 or 2),
* exhibiting molars with anomalies of the enamel/dentin, or
* unable to attend follow-up appointments were excluded from the study.
* A bitewing radiograph was used to assess teeth suspected of having caries on their proximal surfaces, and those with caries were excluded from the study.
What they're measuring
1
retention rates of fissure sealants
Timeframe: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, 18-, and 24 month follow-up visits.