Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
Primary Purpose
Dental Pain and Sensation Disorder, Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
local anaesthetic injection
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain and Sensation Disorder focused on measuring dental anesthesia
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)
Sites / Locations
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SleeperOne
Traditional anesthesia
Arm Description
SleeperOne S4 (Revello S.p.A., Verona, Italy) appliance will be used for the administration of local anesthetic.
Local anesthesia will be performed with a traditional syringe (0480-1, ASA Dental, Massarosa, LU, Italy).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05531435
First Posted
September 3, 2022
Last Updated
September 21, 2022
Sponsor
University of Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05531435
Brief Title
Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
Official Title
Local Anesthesia With SleeperOne® Device vs Traditional Syringe for Restorative Procedures in Pediatric Patients: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain and Sensation Disorder, Dental Caries in Children
Keywords
dental anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth design
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SleeperOne
Arm Type
Experimental
Arm Description
SleeperOne S4 (Revello S.p.A., Verona, Italy) appliance will be used for the administration of local anesthetic.
Arm Title
Traditional anesthesia
Arm Type
Active Comparator
Arm Description
Local anesthesia will be performed with a traditional syringe (0480-1, ASA Dental, Massarosa, LU, Italy).
Intervention Type
Drug
Intervention Name(s)
local anaesthetic injection
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain measure
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Size sensation
Description
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.
Time Frame
Baseline
Title
Bitter sensation
Description
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.
Time Frame
Baseline
Title
Vomit sensation
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to the Principal Investigator.
Citations:
PubMed Identifier
15646908
Citation
Palm AM, Kirkegaard U, Poulsen S. The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset. Pediatr Dent. 2004 Nov-Dec;26(6):481-4.
Results Reference
background
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Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
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