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Effect of amniotic membrane in reduction of postoperative complications after impacted mandibular third molar surgery

Protocol summary

Summary
Purpose. surgical removal of impacted mandibular third molar is one of the most common surgical procedures in the oral cavity which usually accompanies with predictable sequels such as bleeding, swelling, pain and trismus. The aim of this study is to use amniotic membrane as a biological dressing into the socket of extracted mandibular third molar and review its relationship with complications such as pain, swelling and trismus. Study design. Randomized, double-blind, placebo-uncontrolled, single-center, phase one trial. The methodology of the study. In this split mouth study, 26 patients referred to Hamadan dental school with the age range of 64-16 years old with impacted mandibular third molars who had bilaterally and similar impacts are to be reviewed. In this study, the side of the mandible where amniotic membrane is placed inside, it will be considered as the treatment side while the opposite side is control that is randomly selected for each patient. At least 4 weeks interval is considered between surgeries on either side to ensure recovery of the surgery. Surgery and amniotic membrane insertion is implemented by maxillofacial surgeon but the variables were examined by student who is blind to placement or non-placement of amniotic membrane and for this reason this study is blinded both on the patient and the inspector person. Pain level is recorded with VAS scale, swelling is evaluated by inflexible tape by UStün method and trismus is measured by assessing the interincisal distance by digital caliper on 2, 5 and 8 days.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071228892N1
Registration date: 2016-10-02, 1395/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-02, 1395/07/11
Registrant information
Name
Omid Soltaninia
Name of organization / entity
dental school,Hamadan universiity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 38381058
Email address
omid.soltaninia@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of amniotic membrane in reduction of postoperative complications after impacted mandibular third molar surgery
Public title
Effect of amniotic membrane in reduction of postoperative complications after impacted mandibular third molar surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: taking no medications and drugs; healthy patients with ASA 1 category; lack of allergy to local anesthesia; having bilateral mandibular third molar with similar impaction Exclusion criteria: poor oral hygiene; hypersensitivity to amniotic membrane; smoking and alcohol abuse; pregnant and lactating mothers
Age
From 16 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street, Hamadan City, Hamadan, Iran
City
Hamadan
Postal code
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.UMSHA.REC.1395.180

Health conditions studied

1

Description of health condition studied
Correlation between complications associated with impacted mandibular third molar surgery and amniotic membrane
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
days 2 , 5 , 8
Method of measurement
VAS scale

2

Description
swelling
Timepoint
days 2 , 5 , 8
Method of measurement
Sum of 3 distances: 1- tragus to oral commisure; 2- lateral canthus to mandibular angle; 3- tragus to pogonion

3

Description
trismus
Timepoint
days 2 , 5 , 8
Method of measurement
Maximum opening measured between upper and lower incisors

Secondary outcomes

1

Description
patient satisfaction
Timepoint
days 2, 5, 8
Method of measurement
based on planned scale

Intervention groups

1

Description
In this study, side of mandible in which amniotic membrane is applied, is considered treatment group and would be selected randomly for each patient. Surgical removal of contralateral wisdom tooth would be performed at least 4 weeks after first surgery. Fresh amniotic membrane can be preserve into normal saline up to 24 hours. Amniotic membrane is settled into the socket in layered fashion.
Category
Treatment - Other

2

Description
Contralateral side is considered control.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental School, Hamadan University of Medical Sciences
Full name of responsible person
Street address
Shahid Fahmideh Street, Hamadan City, Hamadan, Iran
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Omid Soltaninia
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Dental School
Full name of responsible person
Omid Soltaninia
Position
Asistant Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 1058
Fax
Email
omid.soltaninia@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental School
Full name of responsible person
Omid Soltaninia
Position
Asistant Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hmadan
Postal code
Phone
+98 81 3838 1058
Fax
Email
omid.soltaninia@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Soltaninia
Position
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Hamadan City, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 1058
Fax
Email
omid.soltaninia@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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