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Articaine and Bupivacaine in Impacted Tooth Surgery

NCT ID: NCT04645888

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-02-25

Brief Summary

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Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical procedures with its long duration of action and residual analgesic effect.

The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4% articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action, total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be evaluated.

Detailed Description

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Conditions

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, split-mouth, triple-blinded study was designed.
Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
This was a triple-blinded study in which the surgeon, the patient and the statistician who performed the data analysis did not know which anesthetic solution had been used.

Study Groups

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Articaine

All surgeries were performed by the same surgeon and monitored by the same person. 4 % articaine with 1:200.000 epinephrine was administered to the patients in regional block of the inferior alveolar nerve technique at the first surgery. At the second intervention, patients received the other anesthetic solution which was not used at the first intervention.

1.5 cc of the solution was used to anesthetize the inferior alveolar and lingual nerve and the remaining 0.5 cc was infiltrated to anesthetize the buccal nerve.

Group Type ACTIVE_COMPARATOR

Impacted tooth surgery

Intervention Type PROCEDURE

Surgical extraction of İmpacted tooth

Bupivacaine

All surgeries were performed by the same surgeon and monitored by the same person. % 0.5 bupivacaine without epinephrine was administered to the patients in regional block of the inferior alveolar nerve technique at the first surgery. At the second intervention, patients received the other anesthetic solution which was not used at the first intervention.

1.5 cc of the solution was used to anesthetize the inferior alveolar and lingual nerve and the remaining 0.5 cc was infiltrated to anesthetize the buccal nerve.

Group Type ACTIVE_COMPARATOR

Impacted tooth surgery

Intervention Type PROCEDURE

Surgical extraction of İmpacted tooth

Interventions

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Impacted tooth surgery

Surgical extraction of İmpacted tooth

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients above 18 years of age with bilaterally symmetric, impacted or partially impacted mandibular third molar and patients classified in American Society of Anesthesiologists (ASA) 1 group.

Exclusion Criteria

* Patients with the presence of any systemic diseases, patients allergic to articaine and bupivacaine or any other NSAIDs and patients with analgesic or anti-inflammatory drugs usage in 15 days before to the surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Mehmet Coskunses

Associate Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berkay Tokuc, DDS

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University Faculty of Dentistry

Kocaeli, Basiskele, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id