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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: buccal infiltration of 4% Articaine with Epinephrine; Drug: buccal infiltration of 2% Mepivacaine with Epinephrine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Melaka, Malaysia, 75150
    • Melaka Manipal Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; buccal infiltration of 4% Articaine with epinephrine	Drug: buccal infiltration of 4% Articaine with Epinephrine; Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge; Other Names: Septocaine 4%
Active Comparator: Group B; buccal infiltration of 2% Mepivacaine with epinephrine	Drug: buccal infiltration of 2% Mepivacaine with Epinephrine; Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge; Other Names: Scandonest 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Melaka Manipal Medical College
• Investigators: Principal Investigator: Abdul k Azad, MDS, Melaka Manipal Medical College,Faculty of Dentistry, Manipal Academy of Higher Education

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 17, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate; Mepivacaine; Carticaine
• Other Study ID Numbers: MMMC/FOD/AR/B5/E C-2017(24)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes