A Phase 4 interventional study of buccal infiltration of 4% Articaine with Epinephrine and buccal infiltration of 2% Mepivacaine with Epinephrine in Pain, sponsored by Melaka Manipal Medical College. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Melaka Manipal Medical College · Phase 4, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
buccal infiltration of 4% Articaine with epinephrine
Drug: buccal infiltration of 4% Articaine with Epinephrine
buccal infiltration of 2% Mepivacaine with epinephrine
Drug: buccal infiltration of 2% Mepivacaine with Epinephrine
Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge
Also known as: Septocaine 4%
Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge
Also known as: Scandonest 2%
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).
Time frame: 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).
Time frame: 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).
Time frame: Through the extraction procedure
Response rate
the total number of patients with pain score more than 40 mm in visual Analogue Scale resulting in a palatal injection.
Time frame: Through the extraction procedure
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Melaka Manipal Medical College