Neodymiun:Yttrium Aluminum Garnet Laser in Caries Prevention of Primary Teeth: One-year Follow-up
Recruitment status was Active, not recruiting
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.
Caries in Occlusal Surface of Primary and Permanent Detition
Other: Laser in caries prevention
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Clinical Effect of Neodymiun:Yttrium Aluminum Garnet Laser in Occlusal Caries Prevention of Primary Teeth: One Year Follow up.|
- Clinical evaluation of the presence of dental caries on tooth occlusal surface [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
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.
|Study Start Date:||August 2009|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
The aim of this controlled clinical study was to evaluate the Neodymiun:yttrium aluminum garnet laser, with or without fluoride, in prevention of occlusal caries in the primary dentition. High caries risk children (7.6±1.4 years) were selected for this study and received the following treatments: G1-1st molar was negative control, and the 2nd molar received a resin sealant; G2-1st molar was negative control, and the 2nd molar received laser irradiation (100 milliJoule, 5 Hertz - 0.5 Watts); G3-1st molar received only fluoride gel and the 2nd molar received fluoride gel + laser irradiation; G4-1st molar received only fluoride varnish and the 2nd molar received fluoride varnish + laser irradiation. Patients were followed up to 12 months to evaluate the formation of white-spot lesions and/or caries cavities by three calibrated observers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727804
|School of Dentistry of Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14040-904|