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Evaluation of the preoperative Pregabalin effects on the severity of pain after impacted mandibular third molar surgery

Protocol summary

Study aim
Determining the effect of the preoperative effect of pregabalin on the severity of pain after third molar surgery
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 24 patients, using a coin toss for randomization.
Settings and conduct
The lower jaws of the patients are assigned to two half jaws and randomly assigned to the control group and the other side to the intervention group by tossing a coin. To prevent the impact of previous surgical experience on severity of pain interpretation, the intervention group will undergo surgery for impacted wisdom teeth first, and at least two weeks later, the control group will undergo the same surgery. Patients in the intervention group will receive a 75 mg capsule of pregabalin 30 minutes before surgery, while the control group will receive a placebo. Since the pregabalin capsule and placebo will be identical in size, shape, and color, participants will not be able to differentiate between them. Patients will receive basic surgical treatment. The type of anesthetic drug and the needle gauge will be the same. After surgery, both groups will be prescribed 400 mg of ibuprofen. Pain severity of each patient using the VAS scale will be asked and recorded at 2, 4, 6, and 8 hours post surgery. This study is designed as a parallel study; Also, the place of surgery and the selection of patients will take place in the oral and maxillofacial surgery department of the Gorgan Faculty of Dentistry.
Participants/Inclusion and exclusion criteria
People aged 18 to 50 years with bilateral impacted wisdom teeth and no systemic diseases, no addiction, no allergy to pregabalin and no active oral infection.
Intervention groups
30 minutes before surgery, the intervention group will receive a 75 mg pregabalin capsule and the control group will receive a placebo capsule.
Main outcome variables
Severity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240515061810N1
Registration date: 2024-06-11, 1403/03/22
Registration timing: prospective

Last update: 2024-06-11, 1403/03/22
Update count: 0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Mohammadreza Habibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3236 8157
Email address
hmohammadreza86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the preoperative Pregabalin effects on the severity of pain after impacted mandibular third molar surgery
Public title
Evaluation of the analgesic effect of preoperative pregabalin in impacted mandibular third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged between 18 to 50 years with impacted mandibular third molars and similar degrees of mesioangular impaction.
Exclusion criteria:
Systemic diseases (e.g., osteoporosis, hyperparathyroidism, chronic kidney disease, connective tissue autoimmune diseases, diabetes, thyroid disorders, etc.). Use of medications that may interact with pregabalin (e.g., sedatives, muscle relaxants, anxiolytics, antidepressants, anticonvulsants, oral diabetes medications, and angiotensin inhibitors). History of alcohol addiction. Allergy to pregabalin or related drugs Pregnancy and lactation. Use of analgesic or anti-inflammatory drugs within 24 hours prior to surgery. Clinical or radiographic evidence of active oral inflammation.
Age
From 18 years old to 51 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 2
All patients who have an indication for bilateral impacted mandibular wisdom tooth surgery with mesiangular impaction, Express their written and informed consent to cooperate with the plan and According to the presenter's request, refer to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Golestan University of Medical Sciences, will be evaluated.
Randomization (investigator's opinion)
Randomized
Randomization description
24 patients will be selected using simple sampling method and will be allocated to the Split Mouth design with a total of 48 samples. Simple random allocation will be used, with one side of the jaw assigned to the intervention group and the other side to the control group using a coin toss.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind randomized controlled clinical trial study in which the participants are blinded to the allocation of their left or right jaw to the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees of Golestan University of Medical Sciences
Street address
Gorgan dental school, Shahryar 5th, Shahrak shahryar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4913983632
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.GOUMS.REC.1403.080

Health conditions studied

1

Description of health condition studied
Postoperative pain after mandibular wisdom tooth surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score on the Visual Analog Scale (VAS)
Timepoint
2, 4, 6, and 8 hours after the surgery.
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, the patient will be given an oral capsule pregabalin (a structural analogue of gamma-aminobutyric acid) 75 mg (Actoverco company) along with 50 mL of water 30 minutes before surgery. Control group: In the control group, the patient will be given a placebo capsule (containing white sugar) along with 50 mL of water 30 minutes before surgery. The surgical procedure for impacted wisdom tooth is performed according to standard protocol. For all patients, a triangular flap is created from the mesial aspect of tooth #7 to the distobuccal of the wisdom tooth. After osteotomy, the impacted tooth is extracted by sectioning, and finally, the surgical site is sutured using interrupted silk (3/0) sutures. The materials used include local anesthesia drugs (3 carpules of 2% lidocaine with 100,000/1 epinephrine for inferior alveolar, buccal, and lingual nerve blocks) and the needle size (27 gauge) will be the same. After surgery, gelofen 400 mg (Aborihan Company) will be administered to both groups. It should be noted that the surgery will be performed by a skillfull oral and maxillofacial surgeon.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry Gorgan
Full name of responsible person
Haleh zokaee
Street address
Gorgan dental school, Shahryar 5th, Shahrak shahryar, Gorgan
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7824
Email
Haleh.zokaee@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Deputy of research and technology, Second floor, Central Library Bldg, Gorgan University of Medical Sciences, Shastkola Rd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
n.mirbehbahani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Haleh zokaee
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial department Gorgan dental school Shahryar 5th Shahrak shahryar Gorgan
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7824
Email
Haleh.zokaee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Haleh zokaee
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial department Gorgan dental school Shahryar 5th Shahrak shahryar Gorgan
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7824
Email
Haleh.zokaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Gorgan dental school Shahryar 5th Shahrak shahryar Gorgan
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7824
Email
hmohammadreza86@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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