The purpose of this study is to investigate the effect of premedication with amitriptyline on pain reduction in patients after mandibular impacted third molar surgery.
Design
Two-sided blinded, randomised clinical trial with a parallel group design of 20 patients(40 samples).
Settings and conduct
The current clinical study has case and placebo groups. 20 patients with two impacted mandibular third molars referred for surgery to Dentistry Faculty of Tabriz University were selected and underwent surgery to extract the teeth. One of the teeth will be operated by pretreatment with amitriptyline and the other by pretreatment with placebo. One hour before surgery, patients in the case group will be prescribed a tablet containing 25 mg of amitriptyline, while placebo tablets (sugar tablets) with the same shape and color as amitriptyline will be given to the placebo group. The intensity of pain is measured every 6 hours after surgery - before taking ibuprofen and one hour after taking it - with a 10 cm VAS scale. This information is entered in a questionnaire along with demographic information such as age and gender. Patients and surgeons are blinded to the surgical group.
Participants/Inclusion and exclusion criteria
People with impacted mandibular third molar with similar impaction type on both sides, consent to participate in the study, absence of dental caries and advanced periodontal diseases, absence of pregnancy and taking other drugs that reduce pain two weeks before surgery. Lack of allergy to amitriptyline and systemic disorders that are contraindications for surgery.
Intervention groups
The patient willl take amitriptyline before surgery for the impacted third molar of the mandible on one side and placebo before the surgery of the other tooth on the other side.
Main outcome variables
The intensity of pain every 6 hours after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240419061526N1
Registration date:2024-05-05, 1403/02/16
Registration timing:prospective
Last update:2024-05-05, 1403/02/16
Update count:0
Registration date
2024-05-05, 1403/02/16
Registrant information
Name
Mohammadhosein Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3544 5152
Email address
hhjdentist@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-22, 1403/04/02
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of premedication with amitriptyline on pain control of patients after surgery of impacted mandibular third molar
Public title
The effect of premedication with an antidepressant before surgery of impacted mandibular third molar on pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants with similar impacted third mandibular molars on both left and right sides with similar impaction pattern
Participants with informed consent to participate in the study
Participants with no inflammatory symptoms in the oral cavity such as tooth decay and advanced periodontal diseases
Exclusion criteria:
Participants who are unwilling to participate in the study
Pregnancy
Taking pain-relieving drugs two weeks before surgery
Allergy to amitriptyline
Systemic disorders that are contraindications for surgery, such as high blood pressure and uncontrolled diabetes
Age
From 18 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
In each participant, two impacted third molar teeth will be operated.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization will be used to assign the impacted third molar tooth from one of the two sides to the intervention group and one of the two sides to the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients undergoing surgery and the surgeon do not know the type of pill used before surgery (amitriptyline/placebo) for each side of the mandible.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165933311
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.TBZMED.REC.1402.752
Health conditions studied
1
Description of health condition studied
Impaction of mandibular third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity of patients after surgery
Timepoint
Measuring the pain level of patients every 6 hours after surgery up to 24 hours
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive a 25 mg dose of amitriptyline 1 hour before surgery.
Category
Treatment - Drugs
2
Description
Control group: Patients receive a placebo 1 hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Farrokh Farhadi Shabestari
Street address
Tabriz University of Medical Sciencesو Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
info@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz University of Medical Sciencesو Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
info@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadhosein Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 93, Golbaz alley, Golgasht street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165933311
Phone
+98 41 3544 5152
Fax
Email
hhjdentist@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadhosein Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 93, Golbaz alley, Golgasht street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165933311
Phone
+98 41 3544 5152
Fax
Email
hhjdentist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadhosein Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 93, Golbaz alley, Golgasht street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165933311
Phone
+98 41 3544 5152
Fax
Email
hhjdentist@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information including the age and gender of participants and main outcome information can be shared.
When the data will become available and for how long
Six months after data publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data retrieval is permitted with the permission of the authors and researchers.
From where data/document is obtainable
Through the main researcher, Dr. Mohammad Hossein Asadi by email hhjdentist@gmail.com
What processes are involved for a request to access data/document
The purpose and way of using the data must be clear.