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

NCT03470532 | Completed Phase 4 FDA Drug

• 1 other identifier: MMMC/FOD/AR/B5/E C-2017(24)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Response rate

  Through the extraction procedure

Study Arms (2)

Group A

EXPERIMENTAL

buccal infiltration of 4% Articaine with epinephrine

Drug: buccal infiltration of 4% Articaine with Epinephrine

Group B

ACTIVE COMPARATOR

buccal infiltration of 2% Mepivacaine with epinephrine

Drug: buccal infiltration of 2% Mepivacaine with Epinephrine

Interventions

buccal infiltration of 4% Articaine with Epinephrine DRUG

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

Also known as: Septocaine 4%

Group A

buccal infiltration of 2% Mepivacaine with Epinephrine DRUG

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

Also known as: Scandonest 2%

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with periapical infections.
• Patients who are on concurrent treatment with NSAIDs and corticosteroids

Sponsors & Collaborators

• Melaka Manipal Medical College: lead

Study Sites (1)

Melaka Manipal Medical College

Malacca, 75150, Malaysia

Location

MeSH Terms

Conditions

Pain

Interventions

Carticaine; Epinephrine; Mepivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines

Study Officials

• Abdul k Azad, MDS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dept Of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 20, 2018
• Study Start: February 25, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

MY (1)