Evaluation of Pain Perception and Heart Rate in Children Who Received Dental Anesthesia

NCT03348800 | Completed

• 1 other identifier: RP-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this single-blind split-mouth study is to compare traditional syringe technique versus computer-controlled Wand® anesthetic System to evaluate pain perception, assessed with Visual Numerical Rating Scale, and heart rate in children requiring at least two tooth extractions on opposite sides of the maxilla. The investigators suppose that the feeling of fear during anesthesia administration is related to the use of the conventional syringe and that the pain to the lack of control of the plunger of the syringe. The computer-controlled delivery system allows the operator to hide the needle and to control the pressure exerted during anesthetic administration.

Conditions

Dental Anxiety

Keywords

Child; RCT; Anesthesia; Tooth extraction

Outcome Measures

Primary Outcomes (1)

• Pain felt during dental anesthesia

  Pain will be assessed with the use of a (VNRS) Visual Numerical Rating Scale. Such Scale ranges from 0 to 10 with 0 meaning "no pain" and 10 meaning "the worst pain possible".

  2 minutes after dental anesthesia

Secondary Outcomes (1)

• Heart Rate during dental anesthesia

  2 minutes after and 2 minutes before dental anesthesia

Study Arms (2)

Test Side

EXPERIMENTAL

The side in which computer controlled anesthetic delivery system will be used as dental anesthesia before dental surgery

Procedure: Dental anesthesia

Control Side

ACTIVE COMPARATOR

The side in which conventional syringe will be used as dental anesthesia before dental surgery

Procedure: Dental anesthesia

Interventions

Dental anesthesia PROCEDURE

A tooth extraction will be performed

Also known as: Device: computer controlled delivery system named Wand®

Control Side; Test Side

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• good general health state and no contraindications to local anesthetics

You may not qualify if:

• suffering from any medical condition that could alter pain perception or taking any antibiotic or antinflammatory drugs in the last month before the procedures

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Roma, 00168, Italy

Location

Related Publications (2)

• Garret-Bernardin A, Cantile T, D'Anto V, Galanakis A, Fauxpoint G, Ferrazzano GF, De Rosa S, Vallogini G, Romeo U, Galeotti A. Pain Experience and Behavior Management in Pediatric Dentistry: A Comparison between Traditional Local Anesthesia and the Wand Computerized Delivery System. Pain Res Manag. 2017;2017:7941238. doi: 10.1155/2017/7941238. Epub 2017 Feb 15.

  PMID: 28293129 BACKGROUND

• Patini R, Coviello V, Raffaelli L, Manicone PF, Dehkhargani SZ, Verdugo F, Perfetti G, D'Addona A. Subjective pain response to two anesthetic systems in dental surgery: traditional syringe vs. a computer controlled delivery system. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl):89-97.

  PMID: 23164333 RESULT

MeSH Terms

Interventions

Anesthesia, Dental

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Dentistry

Study Officials

• Massimo Cordaro, MD, Dean

  Catholic University of Sacred Heart

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blindfolded during the tooth extractions and the outcome assessors will be unaware of dental procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Post Graduate Diploma in Oral Surgery

Model Details: This study has a split-mouth model so participants will be anesthetized in one half of the maxilla with a conventional syringe and in the other half with the computer controlled delivery system. The anesthetic techniques will be the same in the two haves.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 21, 2017
• Study Start: November 22, 2017
• Primary Completion: November 22, 2017
• Study Completion: May 21, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)