Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

University of Pavia

Status: Completed

Conditions: Dental Pain and Sensation Disorder; Dental Caries in Children

Treatments: Drug: local anaesthetic injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05531435

2022-SLEEPERONE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

SleeperOne

Experimental group

Description:

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

Treatment:

Drug: local anaesthetic injection

Traditional anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: local anaesthetic injection