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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470532
• Other study ID #: MMMC/FOD/AR/B5/E C-2017(24)
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2018
• Last updated: March 19, 2018
• Start date: February 25, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Melaka Manipal Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with periapical infections.

• Patients who are on concurrent treatment with NSAIDs and corticosteroids

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• buccal infiltration of 4% Articaine with Epinephrine
Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge
• buccal infiltration of 2% Mepivacaine with Epinephrine
Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge

Locations

Country	Name	City	State
Malaysia	Melaka Manipal Medical College	Melaka

Sponsors (1)

Lead Sponsor	Collaborator
Melaka Manipal Medical College

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 minutes after the administration of the drug
Primary	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).	through the extraction procedure
Primary	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).	Through the extraction procedure
Secondary	Response rate	the total number of patients with pain score more than 40 mm in visual Analogue Scale resulting in a palatal injection.	Through the extraction procedure