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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03470532
Enrollment
60
Registered
2018-03-20
Start date
2017-02-25
Completion date
2018-03-01
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGbuccal infiltration of 4% Articaine with Epinephrine

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

DRUGbuccal infiltration of 2% Mepivacaine with Epinephrine

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

Sponsors

Melaka Manipal Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of pain intensity10 minutes after the administration of the drugpain 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).

Secondary

MeasureTime frameDescription
Response rateThrough the extraction procedurethe total number of patients with pain score more than 40 mm in visual Analogue Scale resulting in a palatal injection.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026