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Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination

Primary Purpose

Molar, Third

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Impacted third molar surgey
Sponsored by
Cihan Topan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar, Third focused on measuring pain, trismus, analgesia, ketamine, Ibuprofen

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a fully embedded third molar tooth in the mandible Patients with regular attendance for routine follow up Patients with a healthy general systemic condition Exclusion Criteria: Patients with a fully erupted or partially embedded third molar tooth in the mandible Patients who have previously experienced allergies to NSAIDs, local anesthetics, and ketamine Pregnant or breastfeeding patients Patients who have recently used a different group of NSAIDs for a different condition

Sites / Locations

  • Erciyes University Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intrafen group

Ketamine group

Combined group (Intrafen+Ketamine)

Control

Arm Description

Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia.

Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.

Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the surgery, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.

Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia.

Outcomes

Primary Outcome Measures

The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Trismus was evaluated on the second day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.

Secondary Outcome Measures

The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.
All study participants will record the dose of rescue analgesic medicine (Paracetamol 500 mg) at home if they need to take it within 24 hours following surgery.

Full Information

First Posted
June 16, 2023
Last Updated
September 5, 2023
Sponsor
Cihan Topan
Collaborators
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05923775
Brief Title
Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination
Official Title
Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cihan Topan
Collaborators
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery?
Detailed Description
Materials and methods The study will comprise 100 individuals who requested to have their mandibular third molar tooth extracted at the Erciyes University Faculty of Dentistry. Participants were randomly allocated into four groups, with 25 patients in each group. The first group (Intrafen group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed. The second group (Ketamine group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed. The third group (Combined group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed. The fourth group (Control group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar, Third
Keywords
pain, trismus, analgesia, ketamine, Ibuprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrafen group
Arm Type
Active Comparator
Arm Description
Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia.
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.
Arm Title
Combined group (Intrafen+Ketamine)
Arm Type
Active Comparator
Arm Description
Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the surgery, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Impacted third molar surgey
Intervention Description
The surgery was performed using the classic technique: ten minutes after anesthesia administration, a horizontal and sulcular incision was performed, and a mucoperiosteal envelope flap was elevated. The bone covering the impacted third molar tooth was removed with the use of a surgical handpiece and rotary instrument. During the operation, saline water was applied to the surgical drill with a second hand to protect the bone from developing a high temperature. After extraction of the third molar, the cavity was treated with curettage, irrigated with saline, and sutured.
Primary Outcome Measure Information:
Title
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Description
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Time Frame
The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) two hours following impacted third molar surgery. [All study participants were asked to record their pain levels two hours after surgery].
Title
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Description
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Time Frame
The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) six hours following impacted third molar surgery. [All study participants were asked to record their pain levels six hours after surgery].
Title
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Description
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Time Frame
The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 12 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 12 hours after surgery].
Title
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Description
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Time Frame
The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 24 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 24 hours after surgery].
Title
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
Description
Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Time Frame
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded before surgery].
Title
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Description
Trismus was evaluated on the second day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Time Frame
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded two days after the surgery].
Title
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Description
Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Time Frame
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded seven days after the surgery].
Secondary Outcome Measure Information:
Title
The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.
Description
All study participants will record the dose of rescue analgesic medicine (Paracetamol 500 mg) at home if they need to take it within 24 hours following surgery.
Time Frame
The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a fully embedded third molar tooth in the mandible Patients with regular attendance for routine follow up Patients with a healthy general systemic condition Exclusion Criteria: Patients with a fully erupted or partially embedded third molar tooth in the mandible Patients who have previously experienced allergies to NSAIDs, local anesthetics, and ketamine Pregnant or breastfeeding patients Patients who have recently used a different group of NSAIDs for a different condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cihan Topan, Doctor
Phone
05556456587
Email
cihantopan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suheyb Bilge, Doctor
Phone
05302112349
Email
suheybbilge@hotmail.com
Facility Information:
Facility Name
Erciyes University Faculty of Dentistry
City
Kayseri
ZIP/Postal Code
(0352) 438 06 57
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cihan Topan, Doctor
Phone
05556456587
Email
cihantopan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination

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