Local Anesthetic ComplicationNCT06025825
Comparative Effect of Palatal Injection in Pediatric Patient
An observational study of Local Anesthetic Complication, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Local Anesthetic Complication
- What is being tested?
- Articaine Hydrochloride + Epinephrine and Lidocaine Hydrochloride + Epinephrine
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 5 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 12 years
- All sexes
- Child
Study population: The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication.
Who may be able to join
- The child has no systemic disease
- Absence of acute toothache
- Child's first tooth extraction treatment
- No suspected allergy to benzocaine, lidocaine or articaine
- Comply with Frankl's 3 or Frankl's 4 behavioral assessments
Who cannot join
- Patients who do not want to participate in the study
- Any systemic condition
- Patients with any drug or local anesthetic allergy
- Patient has acute toothache or abscess
- Patients with previous tooth extraction experience
- Frankl 1 and Frankl 2 patients
Trial locations and contacts
1 site in 1 country.
Ceren Tatlı contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım beyazıt University, Faculty of Dentistry
Ankara, 06790
Kevser SANCAK, DDS, +905556446580, kevsersancak89@gmail.com
About this study
Official title: Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient
The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.
Read the detailed description
The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. According to studies, under the assumption that a difference of 5 units in the number of patients would be considered significant, it was planned to include at least 5 patients in each group at 95 power and α=0.05 significance level. However, the number of patients has been updated to 96 by increasing the effect size for more meaningful results.
6 different groups will be formed in patients.
- st group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
- nd group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
- rd group: Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl)
- th group: Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl)
- th group: Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl)
- th group: Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) Behavioral guidance will be given to all patients who have an indication for tooth extraction for various reasons and will be included in the study with the tell-show-do technique before treatment, after clinical and radiographic examinations. Topical anesthesia will be applied with Ultracare 20% benzocaine gel (Ultradent Products Inc., USA) for 1 minute to the mucobuccal fold area closest to the tooth to be extracted. The same application will be applied to the palatal region for the groups that will undergo palatal anesthesia. Then, for group 1, group 3 and group 5, a local anesthetic containing 1:100,000 adrenaline and articaine HCL 4%; For Group 2, Group 4 and Group 6, local anesthetic containing 20 mg/ml+0.0125 mg/ml adrenaline and lidocaine HCL was injected through a 30 gauge dental needle. 0.5 in Group 1 and Group 2. cc will be used for buccal anesthesia, 0.2 cc anesthesia will be used for palatal anaesthesia. For other groups, 1 cc of anesthesia will be administered from the buccal. After the application of local anesthesia, tooth extraction will be performed. All anesthesia applications and tooth extractions will be performed by the same pediatric dentist (E.C.T). Patients will be asked to evaluate their pain after dental anesthesia and tooth extraction separately with VAS. It will also be evaluated by the Physician performing the procedure with the Wong-Baker evaluation scale.
Among the different pain assessment methods reported in the literature, rating scales to measure their intensity are mostly used in clinical studies as they represent themselves. The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line.
The dentist who performed the tooth extraction marked the line representing the level of pain intensity perceived by the patients. The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a scale from 0 to 10 indicated on the scale... Face 0 does not hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine' it denotes.
- Conditions
- Local Anesthetic Complication
- Being tested
- Articaine Hydrochloride + Epinephrine, Lidocaine Hydrochloride + Epinephrine
- Keywords
- local anesthesia, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine Hydrochloride + EpinephrineDrug
Also called ultracaine ds
Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction.
Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction.
Lidocaine Hydrochloride + EpinephrineDrug
Also called jetocaine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group
| Study group | Role | What they receive |
|---|---|---|
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) | Before extraction, buccal and palatal infiltration anesthesia with articaine will perform. Following anesthesia, extraction will carry out. Receives: Drug: Articaine Hydrochloride + Epinephrine | |
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) | Before extraction, buccal and palatal infiltration anesthesia with lidocaine will perform. Following anesthesia, extraction will carry out. Receives: Drug: Lidocaine Hydrochloride + Epinephrine | |
| Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl) | Before extraction, buccal infiltration anesthesia with articaine will perform. After 5 minutes, extraction will carry out. Receives: Drug: Articaine Hydrochloride + Epinephrine | |
| Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl) | Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 5 minutes, extraction will carry out. Receives: Drug: Lidocaine Hydrochloride + Epinephrine | |
| Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl) | Before extraction, buccal infiltration anesthesia with articaine will perform. After 8 minutes, extraction will carry out. Receives: Drug: Articaine Hydrochloride + Epinephrine | |
| Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) | Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 8 minutes, extraction will carry out. Receives: Drug: Lidocaine Hydrochloride + Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain during tooth extraction after anesthesia with VAS
The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line
Measured: baseline and maximum 8 minutes
Evaluation of pain during tooth extraction after anesthesia with Wong-Baker
The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a score from 0 to 10, indicated on the scale. it means that Face 0 doesn't hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine
Measured: baseline and maximum 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start2 May 2023
- Primary completion28 Aug 2023
- Study completion5 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Local Anesthetic ComplicationStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser SANCAK, Ankara Yildirim Beyazıt University
- Investigators
- ceren tatlı, assist.Prof, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025825
- Sponsor's protocol ID
- 26379996/10
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
PubMed 30417227Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24.
PubMed 28646527Uckan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):733-5. doi: 10.1016/j.tripleo.2005.12.005. Epub 2006 Mar 20.
PubMed 17138173
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient
- ClinicalTrials.gov ID
- NCT06025825
- Acronym / sponsor ID
- 26379996/10
- Conditions
- Local Anesthetic Complication
- Keywords
- local anesthesia, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 6 Sep 2023 (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.
The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.
Detailed description
The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. According to studies, under the assumption that a difference of 5 units in the number of patients would be considered significant, it was planned to include at least 5 patients in each group at 95 power and α=0.05 significance level. However, the number of patients has been updated to 96 by increasing the effect size for more meaningful results.
6 different groups will be formed in patients.
- st group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
- nd group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
- rd group: Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl)
- th group: Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl)
- th group: Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl)
- th group: Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) Behavioral guidance will be given to all patients who have an indication for tooth extraction for various reasons and will be included in the study with the tell-show-do technique before treatment, after clinical and radiographic examinations. Topical anesthesia will be applied with Ultracare 20% benzocaine gel (Ultradent Products Inc., USA) for 1 minute to the mucobuccal fold area closest to the tooth to be extracted. The same application will be applied to the palatal region for the groups that will undergo palatal anesthesia. Then, for group 1, group 3 and group 5, a local anesthetic containing 1:100,000 adrenaline and articaine HCL 4%; For Group 2, Group 4 and Group 6, local anesthetic containing 20 mg/ml+0.0125 mg/ml adrenaline and lidocaine HCL was injected through a 30 gauge dental needle. 0.5 in Group 1 and Group 2. cc will be used for buccal anesthesia, 0.2 cc anesthesia will be used for palatal anaesthesia. For other groups, 1 cc of anesthesia will be administered from the buccal. After the application of local anesthesia, tooth extraction will be performed. All anesthesia applications and tooth extractions will be performed by the same pediatric dentist (E.C.T). Patients will be asked to evaluate their pain after dental anesthesia and tooth extraction separately with VAS. It will also be evaluated by the Physician performing the procedure with the Wong-Baker evaluation scale.
Among the different pain assessment methods reported in the literature, rating scales to measure their intensity are mostly used in clinical studies as they represent themselves. The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line.
The dentist who performed the tooth extraction marked the line representing the level of pain intensity perceived by the patients. The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a scale from 0 to 10 indicated on the scale... Face 0 does not hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine' it denotes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) | – | Drug: Articaine Hydrochloride + EpinephrineBefore extraction, buccal and palatal infiltration anesthesia with articaine will perform. Following anesthesia, extraction will carry out. |
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) | – | Drug: Lidocaine Hydrochloride + EpinephrineBefore extraction, buccal and palatal infiltration anesthesia with lidocaine will perform. Following anesthesia, extraction will carry out. |
| Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl) | – | Drug: Articaine Hydrochloride + EpinephrineBefore extraction, buccal infiltration anesthesia with articaine will perform. After 5 minutes, extraction will carry out. |
| Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl) | – | Drug: Lidocaine Hydrochloride + EpinephrineBefore extraction, buccal infiltration anesthesia with lidocaine will perform. After 5 minutes, extraction will carry out. |
| Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl) | – | Drug: Articaine Hydrochloride + EpinephrineBefore extraction, buccal infiltration anesthesia with articaine will perform. After 8 minutes, extraction will carry out. |
| Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) | – | Drug: Lidocaine Hydrochloride + EpinephrineBefore extraction, buccal infiltration anesthesia with lidocaine will perform. After 8 minutes, extraction will carry out. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication.
Key inclusion criteria (5 listed)
- The child has no systemic disease
- Absence of acute toothache
- Child's first tooth extraction treatment
- No suspected allergy to benzocaine, lidocaine or articaine
- Comply with Frankl's 3 or Frankl's 4 behavioral assessments
Key exclusion criteria (6 listed)
- Patients who do not want to participate in the study
- Any systemic condition
- Patients with any drug or local anesthetic allergy
- Patient has acute toothache or abscess
- Patients with previous tooth extraction experience
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 |
|---|---|---|
| Articaine Hydrochloride + EpinephrineAlso: ultracaine dsBuccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction. Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction. | Drug | Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl), Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl), Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) |
| Lidocaine Hydrochloride + EpinephrineAlso: jetocaineBuccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group | Drug | Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl), Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl), Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) |
Primary outcome
Evaluation of pain during tooth extraction after anesthesia with VAS
Time frame: baseline and maximum 8 minutes
The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line
Evaluation of pain during tooth extraction after anesthesia with Wong-Baker
Time frame: baseline and maximum 8 minutes
The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a score from 0 to 10, indicated on the scale. it means that Face 0 doesn't hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 30417227Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
- Background: PubMed 28646527Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24.
- Results publication: PubMed 17138173Uckan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):733-5. doi: 10.1016/j.tripleo.2005.12.005. Epub 2006 Mar 20.
- Individual participant dataSharing planned: Undecided
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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.
Ceren Tatlı contact
ceren tatlı, assist.Prof principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Anesthetic Complication, run by Ankara Yildirim Beyazıt 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevser sancak (+905556446580, kevsersancak89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain during tooth extraction after anesthesia with VAS (time frame: baseline and maximum 8 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025825, which also lists 3 linked publications.
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 6 Sep 2023.