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

NCT ID: NCT03470532

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-25
• Study Completion Date: 2018-03-01

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A

buccal infiltration of 4% Articaine with epinephrine

Group Type: EXPERIMENTAL

buccal infiltration of 4% Articaine with Epinephrine

Intervention Type: DRUG

Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge

Group B

buccal infiltration of 2% Mepivacaine with epinephrine

Group Type: ACTIVE_COMPARATOR

buccal infiltration of 2% Mepivacaine with Epinephrine

Intervention Type: DRUG

Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge

Interventions

buccal infiltration of 4% Articaine with Epinephrine

Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge

Intervention Type: DRUG

buccal infiltration of 2% Mepivacaine with Epinephrine

Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge

Intervention Type: DRUG

Other Intervention Names

Septocaine 4%; Scandonest 2%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Melaka Manipal Medical College

OTHER

Sponsor Role: lead

Responsible Party

Abdul Kalam Azad

Assistant Professor, Dept Of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul k Azad, MDS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Melaka Manipal Medical College

Malacca, , Malaysia

Countries

Malaysia

Other Identifiers

MMMC/FOD/AR/B5/E C-2017(24)

Identifier Type: -

Identifier Source: org_study_id