Dental Anaesthesia Affects Pain Level

August 11, 2021 updated by: Nagehan Yilmaz, Karadeniz Technical University

Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial

Background: Needles are the most feared tools, making anaesthetic injection a worrying practice.

Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that painless anaesthesia.

Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine the anxiety levels and pain experienced by the patients, visual and behavior scales were used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon signed-rank tests were used. p<0.05 was considered significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Trabzon, None Selected, Turkey, 61080
        • Nagehan Yılmaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 8-10 years,
  • systemically healthy,
  • had undergone dental treatment (except for extraction) previously but with at least 1 week passed since then
  • were compatible enough to undergo therapy in the clinic in a sitting position,
  • had infection between the roots with a rate over 1/3, had 2/3 root formation,
  • had been indicated for extraction of the maxillary primary molar teeth (55/65 No. teeth),
  • did not have acute and/or subacute infection of the related or other teeth or mouth and surrounding tissues

Exclusion Criteria:

  • who scored above 41 in the state anxiety subscale and above 44 in the trait anxiety subscale of the Spielberger State-Trait Anxiety Scale (SSAS-SAAS)
  • not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLEEPERONE
Device: DENTAL LOCAL ANESTHESİA
doing local and topical anesthesia with two different device
Experimental: COMFORTIN
Device: DENTAL LOCAL ANESTHESİA
doing local and topical anesthesia with two different device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of scales (wong baker faces pain rating scale)
Time Frame: one year
(0-10) (0= no hurt, 10= hurts worst)
one year
Score of scales (face, legs, activity, cry, consolability)
Time Frame: one year
(0-10) (0= relaxed, 10=severe discomfort)
one year
Score of scales (frankl behavior rating scale)
Time Frame: one year
(1-4) (1= definitely negative, 4=definitely positive)
one year
heart rate (pulse oximeter)
Time Frame: one year
one year
level of opiorphin (from saliva samples)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Collaborators

The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Karadeniz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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