Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

NCT ID: NCT05531435

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2022-09-21

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.

Conditions

Dental Pain and Sensation Disorder; Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SleeperOne

SleeperOne S4 (Revello S.p.A., Verona, Italy) appliance will be used for the administration of local anesthetic.

Group Type: EXPERIMENTAL

local anaesthetic injection

Intervention Type: DRUG

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).

Traditional anesthesia

Local anesthesia will be performed with a traditional syringe (0480-1, ASA Dental, Massarosa, LU, Italy).

Group Type: ACTIVE_COMPARATOR

local anaesthetic injection

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 15646908 (View on PubMed)

Other Identifiers

2022-SLEEPERONE

Identifier Type: -

Identifier Source: org_study_id