Dental Caries in Children Clinical Trial
Official title:
Local Anesthesia With SleeperOne® Device vs Traditional Syringe for Restorative Procedures in Pediatric Patients: Randomized Clinical Trial
The aim of the present study is to assess if there are differences on perceived pain during local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric patients. Patients responding to the inclusion criteria will be asked to participate to the study. After signing the informed consent, they will undergo local anesthesia procedure on first or second primary molars for the subsequent performing of dental filling. The split-mouth design will randomly allocate first or second primary molar from one quadrant to SleeperOne procedure, while the contralateral one will be subdued to local anesthesia with traditional syringe. After the procedure, patients will be asked to assess the perceived pain with a Visual Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of "size" (related to the two instruments), bitter and vomit.
The aim of the present study is to assess if there are differences on perceived pain during local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric patients. Patients responding to the inclusion criteria will be asked to participate to the study. After signing the informed consent, they will undergo local anesthesia procedure on first or second primary molars for the subsequent performing of dental filling. Teeth will be randomly allocated to the two different local anesthesia types according to a split-mouth design: first or second primary molar from one quadrant will undergo SleeperOne anesthesia, while the contralateral one will undergo local anesthesia with traditional syringe. After the procedure, patients will be asked to assess the perceived pain with a Visual Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of size (related to the two instruments), bitter and vomit. Sample size calculation (alfa = 0.05; power = 95%) for two independent study group and a continuous primary endpoint is performed concerning the primary outcome "VAS scale for pain". An expected mean of 2.6 with an expected mean difference of 1.7 and a standard deviation of 1.84 are hypothesized [Palm et al., 2004]; therefore, 30 teeth per group are required and a total of 30 patients for the split-mouth design study should be enrolled. Statistical analysis will be performed. Data normality of distribution will be assessed with Kolmogorov-Smirnov test. Subsequently, the most appropriate test will be conducted to compare VAS differences between the two groups for the four variables "pain", "size", "bitter", "vomit". Linear regressions will be performed to assess of the following independent variables on "pain", "size", "bitter" and vomit": technique, quadrant, dental arch, tooth, dentition, sex, age. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03637309 -
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
|
N/A | |
Recruiting |
NCT04538963 -
Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement
|
N/A | |
Not yet recruiting |
NCT05529433 -
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
|
N/A | |
Completed |
NCT03063307 -
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
|
N/A | |
Recruiting |
NCT05512156 -
Toothbrushing Program in Saudi Arabia "TOPS"
|
N/A | |
Not yet recruiting |
NCT06081868 -
RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
|
N/A | |
Recruiting |
NCT06011005 -
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.
|
N/A | |
Completed |
NCT05645029 -
Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)
|
N/A | |
Recruiting |
NCT04195022 -
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth
|
N/A | |
Recruiting |
NCT04195386 -
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
|
N/A | |
Completed |
NCT03480516 -
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
|
N/A | |
Completed |
NCT03311438 -
Oral Health Intervention Program for Children With Congenital Heart Defects
|
N/A | |
Completed |
NCT05110534 -
Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia
|
N/A | |
Completed |
NCT05638217 -
Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children
|
||
Completed |
NCT02002728 -
Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.
|
N/A | |
Active, not recruiting |
NCT05121584 -
Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
|
N/A | |
Completed |
NCT04666597 -
Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
|
||
Completed |
NCT05652231 -
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
|
||
Completed |
NCT06018584 -
Biostimulation After Tooth Extraction
|
N/A | |
Active, not recruiting |
NCT05902975 -
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
|
N/A |