Third MolarPhase 4NCT02696369

Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

A Phase 4 study testing 2% lidocaine HCl with epinephrine 1:200,000 and 2% lidocaine HCl with epinephrine 1:80,000 in people with Third Molar, run by Huons Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Third Molar
What is being tested?: 2% lidocaine HCl with epinephrine 1:200,000 and 2% lidocaine HCl with epinephrine 1:80,000
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteSouth Korea
Study dates: Dec 2014to Aug 2015
Phase: Phase 4
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age over 19
Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
Mesioangular or horizontal angulation categorized by winter classification

Who cannot join

Allergy or hypersensitivity about the investigated products
Any infection or edema during the extraction
The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
Pregnancy or breast-feeding
Any conditions that the investigator considers not to appropriate for this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Huons
Ansan, Kyeonggi-do, 426791

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

Conditions: Third Molar
Being tested: 2% lidocaine HCl with epinephrine 1:200,000, 2% lidocaine HCl with epinephrine 1:80,000

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2% lidocaine HCl with epinephrine 1:200,000Drug
2% lidocaine HCl with epinephrine 1:80,000Drug

Study groups in NCT02696369
Study group	Role	What they receive
2% Lidocaine HCL:Epinephrine inj.	Experimental	2% Lidocaine HCL with epinephrine 1:200,000 Receives: Drug: 2% lidocaine HCl with epinephrine 1:200,000
2% Lidocaine HCL:Epinephrine inj. (3M)	Active comparator	2% Lidocaine HCl with epinephrine 1:80,000 Receives: Drug: 2% lidocaine HCl with epinephrine 1:80,000

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain visual analogue scale (VAS)
To acess the pain immediately after the surgical extraction of impacted lower third molars
Measured: Immediately after the extraction

Secondary outcomes (8)

Onset time of anesthesia
Measured: Immediately after administration of IP
Local anesthetic duration
Measured: Immediately after onset of anesthesia
Pain VAS
Measured: 2, 4, 6 hours after administration of the investigational product (IP)
Onset time of pain after administration of IP
Measured: Immediately after injection
Bleeding after extraction measured by the operator
Measured: Immediately after extraction
Questionnaire of satisfaction level of the operator
Measured: Immediately after extraction
Questionnaire of satisfaction level of the subjects
Measured: Immediately after extraction
Dosage of administrated IP
Measured: immediately after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Aug 2015

First posted2 Mar 2016 (estimated)
Study startDec 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Third MolarStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02696369
Sponsor's protocol ID: HU-015
Status last verified: Feb 2016
First submitted: 24 Feb 2016
Last updated: 2 Mar 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Accuracy of AI in Positional Classification Between Lower Third Molar and Mandibular Canal
As a Decision-support Tool During Preoperative Assessment
RecruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain

All Third Molar trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars
ClinicalTrials.gov ID: NCT02696369
Acronym / sponsor ID: HU-015
Conditions: Third Molar
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Huons Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 2 Mar 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
2% Lidocaine HCL:Epinephrine inj.	Experimental	Drug: 2% lidocaine HCl with epinephrine 1:200,0002% Lidocaine HCL with epinephrine 1:200,000
2% Lidocaine HCL:Epinephrine inj. (3M)	Active comparator	Drug: 2% lidocaine HCl with epinephrine 1:80,0002% Lidocaine HCl with epinephrine 1:80,000

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age over 19
Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
Mesioangular or horizontal angulation categorized by winter classification

Key exclusion criteria (5 listed)

Allergy or hypersensitivity about the investigated products
Any infection or edema during the extraction
The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
Pregnancy or breast-feeding
Any conditions that the investigator considers not to appropriate for this study

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
2% lidocaine HCl with epinephrine 1:200,000	Drug	2% Lidocaine HCL:Epinephrine inj.
2% lidocaine HCl with epinephrine 1:80,000	Drug	2% Lidocaine HCL:Epinephrine inj. (3M)

Primary outcome

Pain visual analogue scale (VAS)
Time frame: Immediately after the extraction
To acess the pain immediately after the surgical extraction of impacted lower third molars

8 secondary outcomes

Onset time of anesthesia
Time frame: Immediately after administration of IP
Local anesthetic duration
Time frame: Immediately after onset of anesthesia
Pain VAS
Time frame: 2, 4, 6 hours after administration of the investigational product (IP)
Onset time of pain after administration of IP
Time frame: Immediately after injection
Bleeding after extraction measured by the operator
Time frame: Immediately after extraction
Questionnaire of satisfaction level of the operator
Time frame: Immediately after extraction
Questionnaire of satisfaction level of the subjects
Time frame: Immediately after extraction
Dosage of administrated IP
Time frame: immediately after injection

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 2 Mar 2016.

Related trials for Third Molar

Not yet recruitingObservational study
Accuracy of AI in Positional Classification Between Lower Third Molar and Mandibular Canal
As a Decision-support Tool During Preoperative Assessment
RecruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain

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 Phase 4 study testing 2% lidocaine HCl with epinephrine 1:200,000 and 2% lidocaine HCl with epinephrine 1:80,000 in people with Third Molar, run by Huons Co., Ltd. at 1 site in South Korea.

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 5 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 2 Mar 2016. 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 South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pain visual analogue scale (VAS) (time frame: Immediately after the extraction). 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 NCT02696369.

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 2 Mar 2016.