Caries in Occlusal Surface of Primary and Permanent Detition Clinical Trial
Official title:
Clinical Effect of Neodymiun:Yttrium Aluminum Garnet Laser in Occlusal Caries Prevention of Primary Teeth: One Year Follow up.
| Verified date | August 2012 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without fluoride, in prevention of occlusal caries in the primary dentition.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 7 Years to 8 Years |
| Eligibility |
Inclusion Criteria: - subject age of 7 to 8 years, high caries risk (evaluated by oral hygiene, dietary habits and fluoride exposure, according to Kidd 2011), with the first permanent molars without caries cavities, restorations, enamel defects, morphological anomalies and/or signals of fluorosis. Subjects had to be willing to comply with all study procedures and protocols. They had to be residents of Ribeirão Preto or other nearby local communities with the same water fluoridation pattern (to eliminate water fluoridation as a potential con- founding variable). Subjects had to be healthy and the parents or the child legal guardian need to be willing to sign the "Authorization and informed consent for research" form. There were no gender restrictions. Exclusion Criteria: - suffering from systemic diseases, had a significant past or medical history with conditions that may affect oral health (i.e., diabetes, HIV, heart conditions that require antibiotic prophylaxis), were taking medications that may affect the oral flora or salivary flow (e.g., antibiotic use in the past three months, drugs associated with dry mouth / xerostomia), had in-office fluoride treatment within the last three months prior to being enrolled in the study, or were not willing to stop the use of any mouth rinse during the duration of the study. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Brazil | School of Dentistry of Ribeirão Preto | Ribeirão Preto | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical evaluation of the presence of dental caries on tooth occlusal surface | The clinical evaluation of the volunteers was performed 1, 3, 6, 9 and 12 months after treatment application by three different calibrated appraisers who were blind to the performed treatment. The clinical and radiographic assessments of the caries lesions were recorded using the clinical criteria described by Chu et al.,(2009), which was adapted from Ekstrand's visual scoring system, and the sealant evaluation was adapted from Beiruti et al.,(2006) The units of measure are: The scores obtained were considered as the following: V0, V1 and/or R0 represented sound teeth(with no need for restorative treatment), which were assigned a score of 0; V3, V4 and R1 to R3 represented decayed teeth(with a need for restorative treatment), which were assigned a score of 1. Considering the sealant scores, if the tooth evaluated presented with a caries lesion, it was considered to be a decayed tooth(with a need for treatment), regardless the sealant retention status. |
up to 1 year | No |