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

Sponsor

Melaka Manipal Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT03470532

Collaborator

(none)

Enrollment

Location

Arms

12.1

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: buccal infiltration of 4% Articaine with Epinephrine Drug: buccal infiltration of 2% Mepivacaine with Epinephrine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 25, 2017

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A buccal infiltration of 4% Articaine with epinephrine	Drug: buccal infiltration of 4% Articaine with Epinephrine Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge Other Names: Septocaine 4%
Active Comparator: Group B buccal infiltration of 2% Mepivacaine with epinephrine	Drug: buccal infiltration of 2% Mepivacaine with Epinephrine Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge Other Names: Scandonest 2%

Arm

Intervention/Treatment

Experimental: Group A

buccal infiltration of 4% Articaine with epinephrine

Drug: buccal infiltration of 4% Articaine with Epinephrine

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

Other Names:

Septocaine 4%

Active Comparator: Group B

buccal infiltration of 2% Mepivacaine with epinephrine

Drug: buccal infiltration of 2% Mepivacaine with Epinephrine

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

Other Names:

Scandonest 2%

Outcome Measures

Primary Outcome Measures

Measurement of pain intensity [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).
Measurement of pain intensity [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).
Measurement of pain intensity [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 Outcome Measures

Response rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Melaka Manipal Medical College	Melaka		Malaysia	75150

Sponsors and Collaborators

Melaka Manipal Medical College

Investigators

Principal Investigator: Abdul k Azad, MDS, Melaka Manipal Medical College,Faculty of Dentistry, Manipal Academy of Higher Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdul Kalam Azad, Assistant Professor, Dept Of Oral and Maxillofacial Surgery, Melaka Manipal Medical College

ClinicalTrials.gov Identifier:

NCT03470532

Other Study ID Numbers:

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

First Posted:

Mar 20, 2018

Last Update Posted:

Mar 21, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2018