Dental Anaesthesia Affects Pain Level
Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedAugust 12, 2021
August 1, 2021
1 year
July 16, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Score of scales (wong baker faces pain rating scale)
(0-10) (0= no hurt, 10= hurts worst)
one year
Score of scales (face, legs, activity, cry, consolability)
(0-10) (0= relaxed, 10=severe discomfort)
one year
Score of scales (frankl behavior rating scale)
(1-4) (1= definitely negative, 4=definitely positive)
one year
heart rate (pulse oximeter)
one year
level of opiorphin (from saliva samples)
one year
Study Arms (2)
SLEEPERONE
EXPERIMENTALCOMFORTIN
EXPERIMENTALInterventions
doing local and topical anesthesia with two different device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nagehan Yılmaz
Trabzon, None Selected, 61080, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Prof
Study Record Dates
First Submitted
July 16, 2021
First Posted
August 12, 2021
Study Start
July 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share