Skip to main content
OpenTrials
Completed

NCT Number: NCT03470532

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Melaka Manipal Medical College

Malacca, 75150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buccal infiltration of 4% Articaine with Epinephrine

Drug

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

Other names: Septocaine 4%

buccal infiltration of 2% Mepivacaine with Epinephrine

Drug

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

Other names: Scandonest 2%

Primary outcomes

  1. Measurement of pain intensity

    Time frame: 10 minutes after the administration of the drug

    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).

  2. Measurement of pain intensity

    Time frame: through the extraction procedure

    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).

  3. Measurement of pain intensity

    Time frame: 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 outcomes

  1. Response rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Melaka Manipal Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2018
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.