Wisdom ToothNCT05804630
Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws
A study testing Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) in people with Wisdom Tooth and Dental Impaction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of wisdom teeth. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wisdom Tooth, Dental Impaction
- What is being tested?
- Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2023to 31 Jul 2024
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged between 20-60 years old
- Generally healthy or with well-controlled mild systemic diseases (such as well-controlled hypertension, diabetes, or hyperlipidemia)
- Bilateral wisdom teeth with similar difficulty of surgery(according to Pell and Gregory and Winter's classification), which are indicated for surgical removal under local anesthesia
Who cannot join
- Known or suspected allergy to amide-type local anesthetic agents
- With systemic contraindication for tooth extraction, such as poorly-controlled heart diseases or diabetes, and severe liver or kidney diseases. Patients with systolic blood pressure greater than 150 mmHg or less than 90 mmHg or diastolic blood pressure greater than 100 mmHg or less than 60 mmHg are also excluded
- With local contraindication for tooth extraction, such as previous irradiation to the surgical region, acute infection or cellulitis at the surgical region
- Patients during pregnancy or lactation
- Patients taking analgesic or sedatives in 24 hrs
- Intolerant of dental extraction surgery under local anesthesia due to anxiety, dentophobia, or pain
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dentistry National Taiwan University Hospital
Taipei, 100
About this study
Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of wisdom teeth.
Read the detailed description
Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. They are widely used in oral and maxillofacial surgery, endodontic treatment, periodontal treatment, prosthetics and operative dentistry. They not only reduce the pain of the patient during the treatment, but also improve the comfort of the treatment. The most commonly used local anesthetics are Lidocaine and Articaine, whose efficacy and safety have been demonstrated in many literatures: fast-acting, effective in pain control, comfortable, relatively rare allergic reaction, few local and systemic adverse effects.
Among the above-mentioned drugs, Articaine is an anesthetic drug that has been developed and become popular in recent years. In the past, literature pointed out that due to the relationship between the drug concentration and structure of Articaine, its ability to penetrate into bone is better than that of Lidocaine. Some studies even believe that local infiltration with Articaine can replace block anesthesia with Lidocaine; which means, on the one hand, it is more comfortable during anesthesia. On the other hand, it can avoid the potential adverse effects of block anesthesia, such as: hematoma formation and systemic adverse effects caused by intravascular injection.
For exodontia surgery, a quite common surgery for general dentists and oral surgeons, the most commonly used anesthesia techniques are local infiltration and block anesthesia. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of impacted wisdom teeth. Three types of local anesthetics that have been widely used and proven safe were included:
- Xylestesin-A® (1.7mL/cartridge contains 20mg/mL Lidocaine + 1:80,000 epinephrine)
- Octocaine® (1.8mL/cartridge contains 20mg/mL Lidocaine + 1:100,000 epinephrine)
- Orabloc® (1.8mL/cartridge contains 40mg/mL Articaine + 1:100,000 epinephrine)
This study will be a randomized split-mouth clinical study, and it will include 60 healthy adult patients aged between 20-60 years old, who are evaluated by a single surgeon to be suitable for extraction or odontectomy of their impacted third molars (upper or lower jaws) under local anesthesia. This study consists of two experiments. The above 60 patients will be randomly assigned to group 1 or 2, using different anesthetic drugs or anesthesia techniques:
- Group 1: Octocaine® block vs. Xylestesin-A® block
- Group 2: Orabloc® infiltration vs. Octocaine ® block
During the treatment, we will record the patient's subjective anesthesia onset time, the physician's objective anesthesia onset time, the patient's pain scale during surgery, comfort assessment, adverse reactions, postoperative paresthesia, etc. to evaluate the efficacy and safety of these drugs and anesthesia technique.
- Conditions
- Wisdom Tooth, Dental Impaction
- Being tested
- Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)
- Keywords
- Dental anesthesia, Lidocaine, Articaine, Wisdom tooth, Third molar, Impaction
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)Drug
As mentioned in arm/group descriptions. The amount of dental anesthetic agents used during the surgery will be tailored for patient according to their response, which will not exceed the recommended dosage described in the instruction of the product. The amount of the drug used during the surgery will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1, arm 1: Articaine infiltration anesthesia | Active comparator | This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. Receives: Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) |
| Experiment 1, arm 2: Lidocaine block anesthesia | Active comparator | This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. Receives: Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) |
| Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia | Active comparator | This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. Receives: Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) |
| Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia | Active comparator | This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. Receives: Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic measures
Including heart rate (HR)
Measured: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Hemodynamic measures
Blood pressure (Systolic pressure and diastolic pressure)
Measured: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
O2 saturation (SpO2)
O2 saturation (SpO2)
Measured: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Pain and satisfaction of the surgery
Pain according to VAS (0-10) and satisfaction score (1-5, "1" being the least satisfactory and "5" being the most satisfactory)
Measured: Recorded immediate after each dental extraction surgery
Secondary outcomes (1)
Adverse events of anesthesia
Such as headache, dizziness, nausea, vomiting, tachycardia, dyspnea, or post-operative neurosensory disturbance
Measured: Recorded during and interview the patient immediate after each dental extraction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Mar 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Wisdom ToothStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth study design: one dental anesthetic agent at one side (left or right) of mouth and another agent at the other (left or right) side of mouth
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804630
- Sponsor's protocol ID
- 202211014MINB
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liau FL, Kok SH, Lee JJ, Kuo RC, Hwang CR, Yang PJ, Lin CP, Kuo YS, Chang HH. Cardiovascular influence of dental anxiety during local anesthesia for tooth extraction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jan;105(1):16-26. doi: 10.1016/j.tripleo.2007.03.015. Epub 2007 Jul 25.
PubMed 17656135Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000 May;131(5):635-42. doi: 10.14219/jada.archive.2000.0237.
PubMed 10832257Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.
PubMed 15793381Evans G, Nusstein J, Drum M, Reader A, Beck M. A prospective, randomized, double-blind comparison of articaine and lidocaine for maxillary infiltrations. J Endod. 2008 Apr;34(4):389-93. doi: 10.1016/j.joen.2008.01.004. Epub 2008 Feb 7.
PubMed 18358883Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
PubMed 16554198Lai TN, Lin CP, Kok SH, Yang PJ, Kuo YS, Lan WH, Chang HH. Evaluation of mandibular block using a standardized method. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Oct;102(4):462-8. doi: 10.1016/j.tripleo.2005.12.003. Epub 2006 Jun 8.
PubMed 16997112
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Articaine and Lidocaine in Extraction of Wisdom Teeth of Upper and Lower Jaws
- ClinicalTrials.gov ID
- NCT05804630
- Acronym / sponsor ID
- 202211014MINB
- Conditions
- Wisdom Tooth, Dental Impaction
- Keywords
- Dental anesthesia, Lidocaine, Articaine, Wisdom tooth, Third molar, Impaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 7 Apr 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.
Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of wisdom teeth.
Detailed description
Local anesthesia drugs and anesthesia technique play an imperative role in dental treatment. They are widely used in oral and maxillofacial surgery, endodontic treatment, periodontal treatment, prosthetics and operative dentistry. They not only reduce the pain of the patient during the treatment, but also improve the comfort of the treatment. The most commonly used local anesthetics are Lidocaine and Articaine, whose efficacy and safety have been demonstrated in many literatures: fast-acting, effective in pain control, comfortable, relatively rare allergic reaction, few local and systemic adverse effects.
Among the above-mentioned drugs, Articaine is an anesthetic drug that has been developed and become popular in recent years. In the past, literature pointed out that due to the relationship between the drug concentration and structure of Articaine, its ability to penetrate into bone is better than that of Lidocaine. Some studies even believe that local infiltration with Articaine can replace block anesthesia with Lidocaine; which means, on the one hand, it is more comfortable during anesthesia. On the other hand, it can avoid the potential adverse effects of block anesthesia, such as: hematoma formation and systemic adverse effects caused by intravascular injection.
For exodontia surgery, a quite common surgery for general dentists and oral surgeons, the most commonly used anesthesia techniques are local infiltration and block anesthesia. The purpose of this study was to compare the efficacy and safety of different dental local anesthetics drugs and brands in clinical use for the extraction of impacted wisdom teeth. Three types of local anesthetics that have been widely used and proven safe were included:
- Xylestesin-A® (1.7mL/cartridge contains 20mg/mL Lidocaine + 1:80,000 epinephrine)
- Octocaine® (1.8mL/cartridge contains 20mg/mL Lidocaine + 1:100,000 epinephrine)
- Orabloc® (1.8mL/cartridge contains 40mg/mL Articaine + 1:100,000 epinephrine)
This study will be a randomized split-mouth clinical study, and it will include 60 healthy adult patients aged between 20-60 years old, who are evaluated by a single surgeon to be suitable for extraction or odontectomy of their impacted third molars (upper or lower jaws) under local anesthesia. This study consists of two experiments. The above 60 patients will be randomly assigned to group 1 or 2, using different anesthetic drugs or anesthesia techniques:
- Group 1: Octocaine® block vs. Xylestesin-A® block
- Group 2: Orabloc® infiltration vs. Octocaine ® block
During the treatment, we will record the patient's subjective anesthesia onset time, the physician's objective anesthesia onset time, the patient's pain scale during surgery, comfort assessment, adverse reactions, postoperative paresthesia, etc. to evaluate the efficacy and safety of these drugs and anesthesia technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Split-mouth study design: one dental anesthetic agent at one side (left or right) of mouth and another agent at the other (left or right) side of mouth
| Arm | Type | Receives |
|---|---|---|
| Experiment 1, arm 1: Articaine infiltration anesthesia | Active comparator | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. |
| Experiment 1, arm 2: Lidocaine block anesthesia | Active comparator | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)This arm aims to compare efficacy and safety of infiltration anesthesia of Articaine (Orabloc®) to block anesthesia of Lidocaine (Octocaine®). It would be a split-mouth study design. The patient in this arm would be randomly assigned to one anesthetic agent and technique at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent and technique accordingly. |
| Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia | Active comparator | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. |
| Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia | Active comparator | Drug: Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)This arm aims to compare efficacy and safety of block anesthesia of Lidocaine containing different concentration of epinephrine (adrenaline), i.e. Octocaine® (Lidocaine+1:100000 adrenaline) vs. Xylestesin-A® (Lidocaine+1:80000 adrenaline). It would be a split-mouth study design. The patients in this arm would be randomly assigned to one anesthetic agent at one side (left or right) of the wisdom tooth surgery first, and the other side (left or right) of wisdom tooth surgery would use the other anesthetic agent accordingly. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged between 20-60 years old
- Generally healthy or with well-controlled mild systemic diseases (such as well-controlled hypertension, diabetes, or hyperlipidemia)
- Bilateral wisdom teeth with similar difficulty of surgery(according to Pell and Gregory and Winter's classification), which are indicated for surgical removal under local anesthesia
Key exclusion criteria (6 listed)
- Known or suspected allergy to amide-type local anesthetic agents
- With systemic contraindication for tooth extraction, such as poorly-controlled heart diseases or diabetes, and severe liver or kidney diseases. Patients with systolic blood pressure greater than 150 mmHg or less than 90 mmHg or diastolic blood pressure greater than 100 mmHg or less than 60 mmHg are also excluded
- With local contraindication for tooth extraction, such as previous irradiation to the surgical region, acute infection or cellulitis at the surgical region
- Patients during pregnancy or lactation
- Patients taking analgesic or sedatives in 24 hrs
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 |
|---|---|---|
| Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®)As mentioned in arm/group descriptions. The amount of dental anesthetic agents used during the surgery will be tailored for patient according to their response, which will not exceed the recommended dosage described in the instruction of the product. The amount of the drug used during the surgery will be recorded. | Drug | Experiment 1, arm 1: Articaine infiltration anesthesia, Experiment 1, arm 2: Lidocaine block anesthesia, Experiment 2, arm 1: Lidocaine+1:100000 adrenaline block anesthesia, Experiment 2, arm 2: Lidocaine+1:80000 adrenaline block anesthesia |
Primary outcome
Hemodynamic measures
Time frame: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Including heart rate (HR)
Hemodynamic measures
Time frame: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
Blood pressure (Systolic pressure and diastolic pressure)
O2 saturation (SpO2)
Time frame: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery
O2 saturation (SpO2)
Pain and satisfaction of the surgery
Time frame: Recorded immediate after each dental extraction surgery
Pain according to VAS (0-10) and satisfaction score (1-5, "1" being the least satisfactory and "5" being the most satisfactory)
1 secondary outcome
Adverse events of anesthesia
Time frame: Recorded during and interview the patient immediate after each dental extraction surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 17656135Liau FL, Kok SH, Lee JJ, Kuo RC, Hwang CR, Yang PJ, Lin CP, Kuo YS, Chang HH. Cardiovascular influence of dental anxiety during local anesthesia for tooth extraction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jan;105(1):16-26. doi: 10.1016/j.tripleo.2007.03.015. Epub 2007 Jul 25.
- Background: PubMed 10832257Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000 May;131(5):635-42. doi: 10.14219/jada.archive.2000.0237.
- Background: PubMed 15793381Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.
- Background: PubMed 18358883Evans G, Nusstein J, Drum M, Reader A, Beck M. A prospective, randomized, double-blind comparison of articaine and lidocaine for maxillary infiltrations. J Endod. 2008 Apr;34(4):389-93. doi: 10.1016/j.joen.2008.01.004. Epub 2008 Feb 7.
- Background: PubMed 16554198Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
- Background: PubMed 16997112Lai TN, Lin CP, Kok SH, Yang PJ, Kuo YS, Lan WH, Chang HH. Evaluation of mandibular block using a standardized method. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Oct;102(4):462-8. doi: 10.1016/j.tripleo.2005.12.003. Epub 2006 Jun 8.
- 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.
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 Different dental anesthetic agents during wisdom tooth surgery (Orabloc®, Octocaine®, and Xylestesin-A®) in people with Wisdom Tooth and Dental Impaction, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 7 Apr 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 Taiwan. 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?
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?
Hemodynamic measures (time frame: Recorded immediate before local anesthesia, immediate after local anesthesia, 5 minutes after local anesthesia and immediate after surgery). The study lists 4 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 NCT05804630, which also lists 6 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 7 Apr 2023.