Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Local Anesthesia With SleeperOne® Device vs Traditional Syringe for Restorative Procedures in Pediatric Patients: Randomized Clinical Trial

Conditions
-----------------
Dental Pain and Sensation Disorder, Dental Caries in Children

Intervention / Treatment
-----------------
* Drug: local anaesthetic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of dental caries requiring filling with local anesthesia on first or second primary molar presence of dental caries requiring filling with local anesthesia on the contralateral primary molar Exclusion Criteria: gingivitis dental abscesses, facial traumas/injuries drugs (NSAIDS, paracetamol, antibiotics)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SleeperOne<br>SleeperOne S4 (Revello S.p.A., Verona, Italy) appliance will be used for the administration of local anesthetic. | Drug: local anaesthetic injection<br>* Local anesthetic injection of articaine 4% + adrenaline 1/100.000 (Septanest, Septodont, Saint Maur des Fossés, France) with 30G - 9 mm needle (DENTAL HI TEC, ZI de l'Appentière, Mazières-en-Mauges, France).<br>|
| Active Comparator: Traditional anesthesia<br>Local anesthesia will be performed with a traditional syringe (0480-1, ASA Dental, Massarosa, LU, Italy). | Drug: local anaesthetic injection<br>* Local anesthetic injection of articaine 4% + adrenaline 1/100.000 (Septanest, Septodont, Saint Maur des Fossés, France) with 30G - 9 mm needle (DENTAL HI TEC, ZI de l'Appentière, Mazières-en-Mauges, France).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measure | Self-reported pain by the patient immediately after local anesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size sensation | Self-reported sensation of size related to the instruments by the patient after local anesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no size, 10 - very bulky) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no problem with it' and 10 being 'very bulky'). The combination allows children to pick a facial expression, that corresponds with their sensation and see a number that matches it. | Baseline | 
| Bitter sensation | Self-reported sensation of bitter by the patient after local anesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no bitter, 10 - very bitter) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no bitter' and 10 being 'very bitter'). The combination allows children to pick a facial expression, that corresponds with their sensation and see a number that matches it. | Baseline | 
| Vomit sensation | Self-reported sensation of vomit by the patient after local anesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no vomit, 10 - very vomiting at all) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no vomit' and 10 being 'very vomiting'). The combination allows children to pick a facial expression, that corresponds with their sensation and see a number that matches it. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental anesthesia