Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05531435
Other study ID # 2022-SLEEPERONE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2022
Est. completion date September 21, 2022

Study information

Verified date September 2022
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 15 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
local anaesthetic injection
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).

Locations

Country Name City State
Italy Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Pavia Lombardy

Sponsors (1)

Lead Sponsor Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
See also
  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