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Articaine and Bupivacaine in Impacted Tooth Surgery

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Impacted tooth surgery
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Impacted Third Molar Tooth

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kocaeli University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Articaine

Bupivacaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemodynamic Changes
Systolic and diastolic blood pressure, cardiac rate and blood oxygen saturation level were monitored using a patient monitor before beginning of the surgery (T1), 1 min later following the anesthesia (T2) and immediately after the surgery (T3).
Postoperative pain
Postoperative pain was evaluated by Visual Analogue Scale (VAS) ranging from 0 to 10 and patients were instructed to complete the scale in 6th, 12th, 24th, 48th and 72th hours and 7th day postoperatively.

Secondary Outcome Measures

Maximum mouth opening
Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day.
Duration of Surgery
Duration of the surgery, which was determined by the time between the first incision to last suture was recorded.
Onset of anesthetic action
Onset of anesthetic action was be determined by the first sign of numbness of the ipsilateral lower lip, tongue and alveolar mucosa,
Operation time
The time between the first incision and the last suture was evaluated as operation time.
Quality of the anesthesia
The quality of the anesthesia was evaluated by the surgeon which was based on a 3- point category rating scale: Grade 1: no discomfort reported by the patient during the surgery; Grade 2: any discomfort reported by patient during the surgery, without the need of additional anesthesia; Grade 3: any discomfort reported by patient during the surgery, with the need of additional anesthesia.
Intraoperative bleeding
Intraoperative bleeding was rated by the surgeon which based on a 3-point category rating scale as: Grade 1: minimal bleeding; Grade 2: normal bleeding; Grade 3: excessive bleeding.
Surgical difficulty
Surgical difficulty was determined by modified Parant scale as follows: Grade 1: extraction with forceps only; Grade 2: extraction by osteotomy; Grade 3: extraction by osteotomy and coronal section; Grade 4: complex procedures (root section).
Duration of the postoperative anesthesia
Duration of the postoperative anesthesia be determined by the absence of sensibility of ipsilateral lower lip, tongue and alveolar mucosa and duration of the postoperative analgesia determined by the time from the end of the operation to the first naproxen sodium intake.

Full Information

First Posted
November 20, 2020
Last Updated
November 21, 2020
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT04645888
Brief Title
Articaine and Bupivacaine in Impacted Tooth Surgery
Official Title
Evaluation of the Effects of Articaine and Bupivacaine in Impacted Third Molar Tooth Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, split-mouth, triple-blinded study was designed.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Articaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Impacted tooth surgery
Intervention Description
Surgical extraction of İmpacted tooth
Primary Outcome Measure Information:
Title
Hemodynamic Changes
Description
Systolic and diastolic blood pressure, cardiac rate and blood oxygen saturation level were monitored using a patient monitor before beginning of the surgery (T1), 1 min later following the anesthesia (T2) and immediately after the surgery (T3).
Time Frame
60 minutes
Title
Postoperative pain
Description
Postoperative pain was evaluated by Visual Analogue Scale (VAS) ranging from 0 to 10 and patients were instructed to complete the scale in 6th, 12th, 24th, 48th and 72th hours and 7th day postoperatively.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Maximum mouth opening
Description
Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day.
Time Frame
7days
Title
Duration of Surgery
Description
Duration of the surgery, which was determined by the time between the first incision to last suture was recorded.
Time Frame
60 minutes
Title
Onset of anesthetic action
Description
Onset of anesthetic action was be determined by the first sign of numbness of the ipsilateral lower lip, tongue and alveolar mucosa,
Time Frame
10 minutes
Title
Operation time
Description
The time between the first incision and the last suture was evaluated as operation time.
Time Frame
60 minutes
Title
Quality of the anesthesia
Description
The quality of the anesthesia was evaluated by the surgeon which was based on a 3- point category rating scale: Grade 1: no discomfort reported by the patient during the surgery; Grade 2: any discomfort reported by patient during the surgery, without the need of additional anesthesia; Grade 3: any discomfort reported by patient during the surgery, with the need of additional anesthesia.
Time Frame
60 minutes
Title
Intraoperative bleeding
Description
Intraoperative bleeding was rated by the surgeon which based on a 3-point category rating scale as: Grade 1: minimal bleeding; Grade 2: normal bleeding; Grade 3: excessive bleeding.
Time Frame
60 minutes
Title
Surgical difficulty
Description
Surgical difficulty was determined by modified Parant scale as follows: Grade 1: extraction with forceps only; Grade 2: extraction by osteotomy; Grade 3: extraction by osteotomy and coronal section; Grade 4: complex procedures (root section).
Time Frame
60 minutes
Title
Duration of the postoperative anesthesia
Description
Duration of the postoperative anesthesia be determined by the absence of sensibility of ipsilateral lower lip, tongue and alveolar mucosa and duration of the postoperative analgesia determined by the time from the end of the operation to the first naproxen sodium intake.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berkay Tokuc, DDS
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University Faculty of Dentistry
City
Kocaeli
State/Province
Basiskele
ZIP/Postal Code
41190
Country
Turkey

12. IPD Sharing Statement

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Articaine and Bupivacaine in Impacted Tooth Surgery

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