Caries, Dental
Conditions
Keywords
Dentition, Permanent, Glass Ionomer Cements
Brief summary
The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.
Interventions
PROCEDUREGlass ionomer sealant
BEHAVIORALNon-sealant (toothbrushing)
Sponsors
Academic Centre for Dentistry in Amsterdam
Universidade Federal de Pernambuco
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Split-mouth design
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 \].
Exclusion criteria
* patients presenting any physical and/or medical health issues and having non-cooperative behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glass ionomer selants retention | 3, 6, 12, 18, 24 and 36 months | The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant \[Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848\]. Scores 0 and 1 were considered success, whereas score 2 was considered failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in caries status of first permanent molars | 3, 6, 12, 18, 24 and 36 months | The examiners evaluated the presence of caries according to ICDAS \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178\] and caries activity according to Nyvad criteria \[Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260\]. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures. |
| Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities | 3, 6, 12, 18, 24 months | The examiners evaluated the presence of caries according to ICDAS \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178\] and caries activity according to Nyvad criteria \[Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260\]. The comparison between the 2 cities was performed in order to verify if demographic/ population characteristics could interfere in the treatments. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures. |
Outcome results
None listed