The effect of using gelatin sponges impregnated with Triparatide on the incidence of dry socket and pain intensity after tooth extraction.
Design
A clinical trial with a control group(the other side of the same patient's mouth), with parallel groups, double-blind, randomized, phase 3 on 30 patients. The rand function of Excel software was used for randomization.
Settings and conduct
30patients requiring bilateral molars extraction before dental extraction, are selected and fill out a questionnaire and are evaluated in terms of inclusion and exclusion criteria and systemic diseases. In order to blind, two A&B containers will be determined by the second instructor except in screening, during the implementation and analysis of the patients' results, in one triparatide solution 250mcg/2.4mL and in the other container the normal solution will be determined.Then,by the first supervisor and the student in the intervention side, gelatin sponges that have been immersed for 8 minutes in a container containing 250mcg/2.4mL Teriparatide are placed in socket and sutured in figure of eight and on the control side, gelatin sponge is immersed in normal saline and similar actions are taken. At intervals of 24-72 hours and one week, they will be evaluated using the Visual Analysis System (VAS) chart and objective assessment by the data researcher.
Participants/Inclusion and exclusion criteria
Inclusion:
Patient with bilateral indication of low molar eruption
18 to 50 y/o
Exclusion ::
Periapical lesions
Poor oral hygiene
Smokers
Alcoholics
Diabetics
High blood pressure (>STG 2)
Other Systemic Diseases
Canned people
Pregnant people
Intervention groups
A gelatin sponge dipped in Triparatide solution is placed on one side of the patient's mouth in the site of the extracted tooth; and the other soaked in normal saline solution is placed on the other side.
Main outcome variables
Pain;Incidence of Dry socket
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230627058604N1
Registration date:2023-12-26, 1402/10/05
Registration timing:retrospective
Last update:2023-12-26, 1402/10/05
Update count:0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
َAli Choobani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3236 7155
Email address
ali.choobani77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using gelatin sponges impregnated with Triparatide on the incidence of dry socket and pain intensity after tooth extraction
Public title
Triparatide in dry socket and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with an indication for the extraction of lower molar teeth bilaterally (split mouth)
Exclusion criteria:
Peri apical lesions
Poor oral hygiene
Smoking
Alcoholism
Diabetes
Hyper tension (stg 2 =<)
Other systemic disease
Cancerous
Pregnancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Two containers A and B are marked by the health personnel (the second supervisor of the thesis) that there is normal saline in one and the desired drug in the other. Without knowing the container containing the drug, the main researcher and the executive and the evaluator dipped each of the gelatin sponges in two different containers and placed them in the place of the two extracted teeth on both sides of the participant (for example, solution A is always on the left side of the participant, and solution B is placed on the right side of the patient.) Data analysis and drug effect evaluation are done after the completion of clinical procedures and notification of the principal investigator
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
No. 144, Shahid Chamran alley, Mofatteh ave
City
Tabriz
Province
East Azarbaijan
Postal code
5145855359
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.TBZMED.REC.1402.425
Health conditions studied
1
Description of health condition studied
Pain and incidence of dry socket after tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dry socket
Timepoint
24hours, 72hours and one week after extraxtion
Method of measurement
VAS (Visual Analysis System) and objective examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the side of the intervention (for example, the right side of the patient) and the place of the extracted tooth, a gelatin sponge immersed for 8 minutes in Triparatide solution 250 mcg/2.4 mL belonging to Sina Pharmaceutical Company was placed and a figur of eight suture will be applied and by VAS and objective observation of pain and occurrence of dry socket. It is evaluated at intervals of 24-72 hours and one week after tooth extraction. Please note that due to the split mouth study, the other side of the patient will be considered as the control group, and normal saline is used instead of Triparatide.
Category
Treatment - Drugs
2
Description
Considering the split mouth of the other side of the mouth study will be considered as the control group and normal saline will be used instead of triparatide and in double-blind conditions, which will be done in the same way as the intervention side and subsequent examinations.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Faculty of Dentistry, Tabriz
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5145855359
Phone
+98 41 3334 4280
Email
research-vice@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
Farzin Ahmadpour Pournaki
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5145855359
Phone
+98 41 3236 7155
Email
phoenixinfire@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzin Ahmadpour Pournaki
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5145855359
Phone
+98 41 3236 7155
Email
phoenixinfire@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
َAli Choobani
Position
Phd student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No144 , Shahid Chamran alley, Mofatteh ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5145855359
Phone
+98 41 3236 7155
Fax
Email
ali.choobani77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Investigating the effect of triparatide solution on the amount of pain and incidence of dry socket after tooth extraction and all data, including entry and exit criteria, implementation method, study results and documentation, and information of participating patients in a non-identifiable condition with ethical indicators.
When the data will become available and for how long
Beginning the access period since mid 2024
To whom data/document is available
Due to the need for skill and scientific information in the use of triparatide solution and the ability to make clinical judgment for its use, it will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use for systematic review studies
Use for clinical strategy
Use for retrospective studies
Use to conduct similar studies with a new approach
From where data/document is obtainable
Vice President of Research and Technology of Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
Calling via email or visiting in person to the Vice President of Research and Technology of Tabriz University of Medical Sciences and requesting the use of documents according to the mentioned conditions.