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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: buccal infiltration of 4% Articaine with Epinephrine; Drug: buccal infiltration of 2% Mepivacaine with Epinephrine

• Registration Number: NCT03470532
• Lead Sponsor: Melaka Manipal Medical College

Brief 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.

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 Timeline

• Study Start: 2017-02-25
• Status Verified: 2018-03
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-17
• Last Update Submitted: 2018-03-19
• Study First Posted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	buccal infiltration of 4% Articaine with Epinephrine	buccal infiltration of 4% Articaine with epinephrine
Group B	buccal infiltration of 2% Mepivacaine with Epinephrine	buccal infiltration of 2% Mepivacaine with epinephrine

Primary Outcome Measures

Name	Time	Method
Measurement of pain intensity	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Melaka Manipal Medical College; 🇲🇾 Melaka, Malaysia