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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: buccal infiltration of 4% Articaine with Epinephrine
* Drug: buccal infiltration of 2% Mepivacaine with Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>buccal infiltration of 4% Articaine with epinephrine | Drug: buccal infiltration of 4% Articaine with Epinephrine<br>* Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge<br>* Other names: Septocaine 4%;|
| Active Comparator: Group B<br>buccal infiltration of 2% Mepivacaine with epinephrine | Drug: buccal infiltration of 2% Mepivacaine with Epinephrine<br>* Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge<br>* Other names: Scandonest 2%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | the total number of patients with pain score more than 40 mm in visual Analogue Scale resulting in a palatal injection. | Through the extraction procedure |