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OpenTrials
Completed

NCT Number: NCT05002673

Dental Anaesthesia Affects Pain Level

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.

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Key information

Conditions

Dental Anxiety Anesthesia, Local

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nagehan Yılmaz

Trabzon, None Selected, 61080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DENTAL LOCAL ANESTHESİA

Device

doing local and topical anesthesia with two different device

Primary outcomes

  1. Score of scales (wong baker faces pain rating scale)

    Time frame: one year

    (0-10) (0= no hurt, 10= hurts worst)

  2. Score of scales (face, legs, activity, cry, consolability)

    Time frame: one year

    (0-10) (0= relaxed, 10=severe discomfort)

  3. Score of scales (frankl behavior rating scale)

    Time frame: one year

    (1-4) (1= definitely negative, 4=definitely positive)

  4. heart rate (pulse oximeter)

    Time frame: one year

  5. level of opiorphin (from saliva samples)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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