Dental AnxietyNCT05002673
Dental Anaesthesia Affects Pain Level
A study testing DENTAL LOCAL ANESTHESİA in people with Dental Anxiety and Anesthesia, Local, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Anesthesia, Local
- What is being tested?
- DENTAL LOCAL ANESTHESİA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Anxiety, Anesthesia, Local
- Being tested
- DENTAL LOCAL ANESTHESİA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENTAL LOCAL ANESTHESİADevice
doing local and topical anesthesia with two different device
| Study group | Role | What they receive |
|---|---|---|
| SLEEPERONE | Experimental | Not described Receives: Device: DENTAL LOCAL ANESTHESİA |
| COMFORTIN | Experimental | Not described Receives: Device: DENTAL LOCAL ANESTHESİA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of scales (wong baker faces pain rating scale)
(0-10) (0= no hurt, 10= hurts worst)
Measured: one year
Score of scales (face, legs, activity, cry, consolability)
(0-10) (0= relaxed, 10=severe discomfort)
Measured: one year
Score of scales (frankl behavior rating scale)
(1-4) (1= definitely negative, 4=definitely positive)
Measured: one year
heart rate (pulse oximeter)
Measured: one year
level of opiorphin (from saliva samples)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nagehan Yilmaz, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002673
- Sponsor's protocol ID
- Karadeniz
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial
- ClinicalTrials.gov ID
- NCT05002673
- Acronym / sponsor ID
- Karadeniz
- Conditions
- Dental Anxiety, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLEEPERONE | Experimental | Device: DENTAL LOCAL ANESTHESİA |
| COMFORTIN | Experimental | Device: DENTAL LOCAL ANESTHESİA |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DENTAL LOCAL ANESTHESİAdoing local and topical anesthesia with two different device | Device | COMFORTIN, SLEEPERONE |
Primary outcome
Score of scales (wong baker faces pain rating scale)
Time frame: one year
(0-10) (0= no hurt, 10= hurts worst)
Score of scales (face, legs, activity, cry, consolability)
Time frame: one year
(0-10) (0= relaxed, 10=severe discomfort)
Score of scales (frankl behavior rating scale)
Time frame: one year
(1-4) (1= definitely negative, 4=definitely positive)
heart rate (pulse oximeter)
Time frame: one year
level of opiorphin (from saliva samples)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DENTAL LOCAL ANESTHESİA in people with Dental Anxiety and Anesthesia, Local, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of scales (wong baker faces pain rating scale) (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.