PainPhase 4NCT03470532

Comparing Articaine and Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction

A Phase 4 study testing buccal infiltration of 4% Articaine with Epinephrine and buccal infiltration of 2% Mepivacaine with Epinephrine in people with Pain, run by Melaka Manipal Medical College at 1 site in Malaysia.

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 compares the the efficacy of buccal infiltration of 4% Articaine and 2% Mepivacaine without any palatal injection during extraction of maxillary teeth. One group of patient receives buccal infiltration of Articaine and another group receives buccal infiltration of Mepivacaine. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: buccal infiltration of 4% Articaine with Epinephrine and buccal infiltration of 2% Mepivacaine with Epinephrine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteMalaysia
Study dates: 25 Feb 2017to 1 Mar 2018
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients aged 18 years and above
Patients requiring extraction of maxillary teeth which are grossly decayed, grade I mobile, root stumps or indicated for therapeutic extractions.
Healthy patients ( ASA I ) or patients with mild systemic disease with no functional limitations (ASA II).
Patients who are not allergic to the drugs used in the study

Who cannot join

Patients with periapical infections.
Patients who are on concurrent treatment with NSAIDs and corticosteroids

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Melaka Manipal Medical College
Malacca, 75150

Other trials in Malaysia

About this study

Official title: Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial

Read the detailed description

Dense local anesthesia is required to reduce pain during extraction of tooth. Administration of local anesthesia to the palatal mucosa is proved to be the most painful due to its firm adherence to the underlying periosteum and also it's abundant nerve supply. Articaine has greater lipid solubility and high bone penetration property. Mepivacaine is proven to be the safest local anaesthetic agent. Avoidance of a palatal injection during extraction will benefit the patient by reducing pain and anxiety to a greater extent.

So this study compares the bone penetration property between Articaine and Mepivacaine by assessing the pain in the palatal mucosa while extracting the tooth using only buccal infiltration.

Conditions: Pain
Being tested: buccal infiltration of 4% Articaine with Epinephrine, buccal infiltration of 2% Mepivacaine with Epinephrine
Medical subject headings: Pain

What participants receive

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

buccal infiltration of 4% Articaine with EpinephrineDrug
Also called Septocaine 4%
Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge
buccal infiltration of 2% Mepivacaine with EpinephrineDrug
Also called Scandonest 2%
Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge

Study groups in NCT03470532
Study group	Role	What they receive
Group A	Experimental	buccal infiltration of 4% Articaine with epinephrine Receives: Drug: buccal infiltration of 4% Articaine with Epinephrine
Group B	Active comparator	buccal infiltration of 2% Mepivacaine with epinephrine Receives: Drug: buccal infiltration of 2% Mepivacaine with Epinephrine

What is being measured

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

Measurement of pain intensity
pain intensity in the palatal mucosa is measured using Visual Analogue Scale during instrumentation to check objective symptoms of numbness. The pain is marked from 0-100 mm in a 100 mm visual analogue scale ( 0= no pain, 100= extremely severe pain).
Measured: 10 minutes after the administration of the drug
Measurement of pain intensity
pain intensity in the palatal mucosa is measured using Visual Analogue Scale during flap elevation procedure . The pain is marked from 0-100 mm in a 100 mm visual analogue scale ( 0= no pain, 100= extremely severe pain).
Measured: through the extraction procedure
Measurement of pain intensity
pain intensity is measured using Visual Analogue Scale during extraction of tooth. The pain is marked from 0-100 mm in a 100 mm visul analogue scale ( 0= no pain, 100= extremely severe pain).
Measured: Through the extraction procedure

Secondary outcomes (1)

Response rate
the total number of patients with pain score more than 40 mm in visual Analogue Scale resulting in a palatal injection.
Measured: Through the extraction procedure

Timeline

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

25 Feb 20171 Mar 2018

First posted20 Mar 2018
Study start25 Feb 2017
Primary completion1 Mar 2018
Study completion1 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03470532
Sponsor's protocol ID: MMMC/FOD/AR/B5/E C-2017(24)
Status last verified: Mar 2018
First submitted: 9 Mar 2018
Last updated: 21 Mar 2018
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: 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

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03470532
Acronym / sponsor ID: MMMC/FOD/AR/B5/E C-2017(24)
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Melaka Manipal Medical CollegeUniversity, hospital or other
Study start: 25 Feb 2017 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 1 Mar 2018 (actual)
First posted: 20 Mar 2018 (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.

Detailed description

So this study compares the bone penetration property between Articaine and Mepivacaine by assessing the pain in the palatal mucosa while extracting the tooth using only buccal infiltration.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: buccal infiltration of 4% Articaine with Epinephrinebuccal infiltration of 4% Articaine with epinephrine
Group B	Active comparator	Drug: buccal infiltration of 2% Mepivacaine with Epinephrinebuccal infiltration of 2% Mepivacaine with epinephrine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients aged 18 years and above
Patients requiring extraction of maxillary teeth which are grossly decayed, grade I mobile, root stumps or indicated for therapeutic extractions.
Healthy patients ( ASA I ) or patients with mild systemic disease with no functional limitations (ASA II).
Patients who are not allergic to the drugs used in the study

Key exclusion criteria (2 listed)

Patients with periapical infections.
Patients who are on concurrent treatment with NSAIDs and corticosteroids

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
buccal infiltration of 4% Articaine with EpinephrineAlso: Septocaine 4%Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge	Drug	Group A
buccal infiltration of 2% Mepivacaine with EpinephrineAlso: Scandonest 2%Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge	Drug	Group B

Primary outcome

Measurement of pain intensity
Time frame: 10 minutes after the administration of the drug
pain intensity in the palatal mucosa is measured using Visual Analogue Scale during instrumentation to check objective symptoms of numbness. The pain is marked from 0-100 mm in a 100 mm visual analogue scale ( 0= no pain, 100= extremely severe pain).
Measurement of pain intensity
Time frame: through the extraction procedure
pain intensity in the palatal mucosa is measured using Visual Analogue Scale during flap elevation procedure . The pain is marked from 0-100 mm in a 100 mm visual analogue scale ( 0= no pain, 100= extremely severe pain).
Measurement of pain intensity
Time frame: Through the extraction procedure
pain intensity is measured using Visual Analogue Scale during extraction of tooth. The pain is marked from 0-100 mm in a 100 mm visul analogue scale ( 0= no pain, 100= extremely severe pain).

1 secondary outcome

Response rate
Time frame: Through the extraction procedure

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 21 Mar 2018.

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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.

Abdul k Azad, MDS principal investigator

Melaka Manipal Medical College,Faculty of Dentistry, Manipal Academy of Higher Education

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 21 Mar 2018. 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 Malaysia. 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?

Measurement of pain intensity (time frame: 10 minutes after the administration of the drug). The study lists 3 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 NCT03470532.

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 21 Mar 2018.