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Effects of Platelet-rich fibrin (PRF) on Post-surgical Complications of Impacted wisdom tooth surgery in adults

Protocol summary

Study aim
Study of effects of platelet-rich fibrin on post-operative complications of mandibular impacted wisdom tooth surgery in adults
Design
Two arm parallel group randomized clinical trial , intervention and control are in a same person, double blinded, on 30 patients, randomized by Balanced (permuted) block randomization
Settings and conduct
Choosing patients based on entrance criteria. Similarity of surgery hardness is asserted by the expert surgeon. Patient assessment and taking informed asset form. Getting 10 ccs vascular blood sample before each operation. PRF preparation and placement after tooth extracted by surgeon. Using a same flap, bur, suturing cord and type of suture and irrigator. Prescription of Paracetamol, Amoxicillin and CHX for one week. Assessment of pain( due to NRS table), edema, bleeding, infection or dry socket for 24 and 72 hours and 7 days after surgery. Patients are blind because of getting blood sample on each operation.
Participants/Inclusion and exclusion criteria
Adult patients with bilateral inter-bone impacted wisdom tooth would be included in the study. Patient who are pregnant, lactating or having pre-operative sign or symptom, pathology in impaction area or allergy to Penicillin, Paracetamol, chlorhexidine would be excluded.
Intervention groups
In each patient, one side of the mouth would be intervention side and the other side is control. In intervention side, PRF taken from patient's blood, would be placed in empty socket of extracted tooth and surgical flap would be sutured. In control side, surgical flap would be sutured without placement of any material.
Main outcome variables
Difference or similarity between intervention and control side

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201227049849N1
Registration date: 2021-01-13, 1399/10/24
Registration timing: registered_while_recruiting

Last update: 2021-01-13, 1399/10/24
Update count: 0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Parisa Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
kiani-p@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Platelet-rich fibrin (PRF) on Post-surgical Complications of Impacted wisdom tooth surgery in adults
Public title
Effects of Platelet-rich-fibrin on Post-surgical Complications of Impacted wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults Patients with bilateral inter-bone impacted wisdom tooth
Exclusion criteria:
Pregnancy Lactation Having pre-operative sign or symptom Existence of pathology in impaction area Allergy to Penicillin, Paracetamol, chlorhexidine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
In each patient, on side of the mouth would be the intervention side and the other side would be the control side.
Randomization (investigator's opinion)
Randomized
Randomization description
For randomizing each left or right side wisdom tooth of cases in intervention or control group, at first, a randomizing list would be gotten from this website www. sealedenvelope.com/simple with Balanced (permuted) block randomization technic and based on the entrance number of each case, left or right side wisdom tooth of patients would be allocate to group A (control group) or group B (intervention group).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient's blood samples would be gotten before each operation( whether for intervention side or control side).Therefore, patients would not be aware of intervention or control side. Data analyzer would receive the data as left side and right side instead of intervention side and control side.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Science
Street address
Pezeshk Blvd, Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-12-09, 1399/09/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.158

Health conditions studied

1

Description of health condition studied
Platelet-rich fibrin
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
post-operative pain degree
Timepoint
First 7 days after surgery
Method of measurement
0-10 Numeric Pain Rating Scale

2

Description
post-operative edema amount
Timepoint
1,3 and 7 days after surgery
Method of measurement
The distance between tragus and mouth commissure in horizontal plane and the distance between lateral cantus and gonion in vertical plane, would be measured by a flexible band.

3

Description
post-operative bleeding amount
Timepoint
3 and 7 days after surgery
Method of measurement
Massive, uncontrollable bleeding since 2nd day of surgery would be conformed by patient.

4

Description
Post-operative infection manifestation
Timepoint
4- 7 days after surgery
Method of measurement
Assessment of pus discharge, redness and temperature increasing after the 3rd day after surgery

5

Description
Post-operative dry socket manifestation
Timepoint
4- 7 days after surgery
Method of measurement
Presence of extreme pain not being decreased by taking analgesics and empty socket without pus discharge or fever

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Placement of Platelet-rich fibrin taken from patient's blood sample in empty extracted tooth socket and suturing the flap with 3/0 silk cord
Category
Prevention

2

Description
Control group: Not placing any material in extracted tooth socket. Suturing the flap with 3/0 silk cord.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Dental School
Full name of responsible person
Amirsalar Sayedyahossein
Street address
Pezeshk Blvd, Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
sayedyahossein-a@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amirsalar Sayedyahossein
Street address
Pezeshk Blvd, Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
sayedyahossein-a@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan University of Medical Science
Proportion provided by this source
4
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
Kashan University of Medical Sciences
Full name of responsible person
امیرسالار سیدیاحسین
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pezeshk Blvd, Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
kiani-p@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amirsalar Sayedyahossein
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pezeshk Blvd.Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
kiani-p@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Parisa Kiani
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pezesh Blvd, Ghotb ravandi Ave
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
kiani-p@kaums.ac.ir

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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