Evaluation of the effect of Chitosan biodegradable scaffold in prevention of alveolar osteitis following mandibular impacted third molar surgical extraction
Design
Parallel randomized controlled clinical trial with a ratio of 1:1 and with superiority design, double-blind, phase 3 on 176 patients, using blocked randomization method
Settings and conduct
In this clinical trial, patients who referred to oral and maxillofacial surgery department of Kermanshah Dental School for surgery of impacted mandibular third molar will be studied. Two groups that have the inclusion criteria, will be randomly assigned to the intervention group (treatment with Chitosan biodegradable scaffold) and control (routine treatment without Chitosan biodegradable scaffold). In this study, patients and statistician are not aware of the treatment status of the participants.
In all patients, tooth extraction is surgically performed routinely and then Chitosan biodegradable scaffold is placed in the sockets of the extracted teeth for the intervention group. Patients will be evaluated for AO on the third and seventh days after surgery.
Participants/Inclusion and exclusion criteria
Patients over 18 years old, needing impacted third molar extraction surgery, who refer to oral surgery department of Kermanshah Dental School; volunteering to participate in this trial.
Intervention groups
In this study, two groups that have the inclusion criteria will be randomly assigned to the intervention group (treatment with Chitosan biodegradable scaffold) and control (routine treatment without the use of Chitosan biodegradable scaffold).
Main outcome variables
Incidence of alveolar osteitis will be compared between the two study groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045516N4
Registration date:2021-01-11, 1399/10/22
Registration timing:prospective
Last update:2021-01-11, 1399/10/22
Update count:0
Registration date
2021-01-11, 1399/10/22
Registrant information
Name
hamed Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 2842
Email address
hamed.nazari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Chitosan biodegradable scaffold in prevention of alveolar osteitis
Public title
The effect of Chitosan biodegradable scaffold in prevention of extracted tooth dry socket
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need of surgical extraction of the mandibular third molar who refer to oral surgery department of Kermanshah dental school
Patients with risk factors for alveolar osteitis (history of pericoronitis, smoking, use of OCPs, history of alveolar osteitis)
Exclusion criteria:
Surgical complications in surgeon's opinion
Antibiotic therapy regimen
Patients' unwillingness to cooperate with the trial
Loss to follow up
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be divided into two equal groups by using the blocked randomization method and considering the number of samples required from the sample size formula. The process is done using block sizes of 6 and 8. Blocking will already be done by randomization online software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of specified intervention groups in this process remains by the coordinator. The dentist who is responsible for assessing the inclusion/exclusion criteria and registration of people will not know about this process. There is a closed envelope for each patient that was located a random 4-digit numerical code on each envelope determines which group the patient is in. Whether each code is specific to what group is written inside a table that was written by someone who have not participated in the process of study. This study is a double-blind clinical trial (in which patients and a statistician have been blinded).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Research - Kermanshah University of Medical Sciences
Street address
Committee of Ethics in Research, Vice chancellor for research and technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.KUMS.REC.1399.877
Health conditions studied
1
Description of health condition studied
Alveolar osteitis
ICD-10 code
K10.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
Incidence of alveolar osteitis after surgical extraction of mandibular impacted third molars
Timepoint
3rd and 7th days after surgery
Method of measurement
Clinical diagnosis of alveolar osteitis by an experienced oral and maxillofacial surgeon regarding the signs and symptoms including: uncontrollable pain with analgesics between the first and third days to the week after tooth extraction with one or a combination of these signs: absence or insufficient blood clot in the socket, Detritus, exposed alveolar bone with or without halitosis
Secondary outcomes
1
Description
Pain intensity after surgery
Timepoint
3rd and 7th days after surgery
Method of measurement
Using Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: Chitosan biodegradable scaffold is placed in the sockets of the extracted teeth after surgery. (The process of making scaffold is done by using chitosan polymer which is biodegradable. The Chitosan is prepared by Chitin deacetylase.)
Category
Prevention
2
Description
Control group: Routine treatment without the use of Chitosan biodegradable scaffold is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences - Dental School
Full name of responsible person
Hamed Nazari
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
hamed.nazari@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
hamed.nazari@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
hamed.nazari@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Fatehi
Position
ُStudent
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
Behnamfatehi@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD