Determining the effect of collagen plug in socket repair after surgical extraction of semi-impacted third molar
Design
Single-group clinical trial without blinding, trial phase does not apply, on 30 patients.
Settings and conduct
The study site is the dental clinics of Hamadan, which collagen plugs are used for patients on the left or right side. In this study, blinding is not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate for bilateral surgery of Semi-impacted wisdom teeth of the mandible and Be in a PELL & GEORGI class one. Exclusion criteria:Patients with systemic disease, clotting or bone problems.
Intervention groups
Intervention group: After the surgery of the semi-impacted tooth and before the wound is sutured, a collagen plug with the brand name BONEPROTECT CONE, produced by the German company DENTEGRIS, is inserted into the remaining cavity of the tooth and then it is sutured. The treatment is performed only in one session and in the next visits, the patient is followed only to evaluate the signs and symptoms.
Main outcome variables
Repair of dental socket
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N8
Registration date:2020-08-08, 1399/05/18
Registration timing:registered_while_recruiting
Last update:2020-08-08, 1399/05/18
Update count:0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-11, 1399/04/21
Expected recruitment end date
2020-10-12, 1399/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of collagen plug in socket repair after surgical extraction of semi-impacted third molar
Public title
Effect of collagen plug in socket repair after surgical extraction of third molar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for bilateral surgery of Semi-impacted wisdom teeth of the mandible
Be in a PELL & GEORGI class one.
Exclusion criteria:
Patients with systemic disease
Clotting problems
Bone problems
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan of University of Medical Sciences
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
7615665175
Approval date
2020-06-04, 1399/03/15
Ethics committee reference number
IR.UMSHA.REC.1399.339
Health conditions studied
1
Description of health condition studied
Repair of dental socket
ICD-10 code
K08.52
ICD-10 code description
Unrepairable overhanging of dental restorative materials
Primary outcomes
1
Description
Repair of dental socket after third molar surgery
Timepoint
At intervals of day 2, the first week and the second week, the patient is evaluated for the desired indicators
Method of measurement
Maximum distance between the edges of the upper and lower incisors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the surgery of the semi-impacted tooth and before the wound is sutured, a collagen plug with the brand name BONEPROTECT CONE, produced by the German company DENTEGRIS, is inserted into the remaining cavity of the tooth and then it is sutured. The treatment is performed only in one session and in the next visits, the patient is followed only to evaluate the signs and symptoms.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Hamadan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciencesو Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@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