Fissure Sealant
Conditions
Keywords
caries, prevention, glass ionomer material, fissure sealant
Brief 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.
Detailed description
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. This randomized, controlled, double-blind, split-mouth clinical trial was conducted with approval from the Medhical Ethics Committee of İzmir Kâtip Çelebi University (14/100) and registered at ClinicalTrials.gov (NCT07110701). The study included 200 healthy children (ASA I), aged 6-12 years, with moderate caries risk. A total of 400 sealants were applied to the two fully erupted mandibular first molars of each participant. Following randomization, one molar received GC Fuji Triage (high-fluoride containing/control), while the contralateral molar received either GC Fuji VII EP (CPP-ACP-containing) or GCP Glass Seal (nano-fluorohydroxyapatite-containing). Applications were performed by a single clinician in accordance with manufacturers' instructions. Patients were evaluated at 3-, 6-, 12-, 18-, and 24-months. Retention, marginal integrity, marginal discoloration, and secondary caries were assessed using modified USPHS criteria. Occlusal caries progression was monitored via ICDAS-II codes and DIAGNOdent measurements
Interventions
OTHERRetention of Fissure Sealants
Other: Retention of the fissure sealants evaluated Description: Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study was carried out as a double-blinded trial, whereby neither the patients nor the clinical evaluator was aware of what material was applied to each tooth. No blinding was done during the treatment period because all treatments were performed by one dentist. The randomization process was applied with two phases to ensure unbiased allocation of the fissure sealant materials to the participants. In the first phase of the randomization, which material groups (GC Fuji Triage -GCP Glass Seal/GC Fuji Triage-GC Fuji VII EP) would be applied to each patient was determined using a computer-generated randomization online tool (htpp//randomizer.org). In the second phase of the randomization, the allocation of the material to either the left or right mandibular molar of each participant was established through the coin toss method (heads or tails), and the opposing molar tooth was treated with the other material in accordance with the group designated by the first randomization.
Intervention model description
randomized, controlled, double-blind, split-mouth design A total of 400 sealants were applied to the two fully erupted mandibular first molars of each participant. Following randomization, one molar received GC Fuji Triage (high-fluoride containing/control), while the contralateral molar received either GC Fuji VII EP (CPP-ACP-containing) or GCP Glass Seal (nano-fluorohydroxyapatite-containing).
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| retention rates of fissure sealants | 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. | Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIREBRU KUCUKYİLMAZ, PROFESSOR
İZMİR KATIP CELEBI UNİVERSİTY
Outcome results
None listed