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Effectiveness of mannitol on postoperative complications after impacted mandibular third molar surgery

Protocol summary

Study aim
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 mannitol and review its relationship with complications such as pain, swelling and trismus
Design
Randomized, double-blind, placebo-uncontrolled, single-center, phase one trial
Settings and conduct
In this split mouth study, 30 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. At least 4 weeks interval is considered between surgeries on either side to ensure recovery of the surgery. Surgery is implemented by maxillofacial surgeon but the variables were examined by student who is blind to use or non-use of mannitol and for this reason this study is blinded both on the patient and the inspector person
Participants/Inclusion and 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 mannitol, smoking and alcohol abuse, pregnant and lactating mothers
Intervention groups
In this study, the side of the mandible where mannitol is infused will be considered as the treatment side while the opposite side is control that is randomly selected for each patient.
Main outcome variables
Pain level is recorded with VAS scale, swelling is evaluated by inflexible tape and trismus is measured by assessing the interincisal distance by digital caliper on 2, 4, 6 and 8 days

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160712028892N2
Registration date: 2019-01-17, 1397/10/27
Registration timing: prospective

Last update: 2019-01-17, 1397/10/27
Update count: 0
Registration date
2019-01-17, 1397/10/27
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
Expected recruitment start date
2019-02-01, 1397/11/12
Expected recruitment end date
2020-01-16, 1398/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mannitol on postoperative complications after impacted mandibular third molar surgery
Public title
Effectiveness of mannitol on 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 Smoking and alcohol abuse Pregnant and lactating mothers
Age
From 16 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
Side of mandible in which mannitol is applied, is considered treatment group and Contralateral side is considered control.
Randomization (investigator's opinion)
Randomized
Randomization description
Choosing the third molar of the mandible in either side of the patient by throwing the coin. Simple randomization or unrestricted method will be used and randomization unit is Individual
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgery is implemented by maxillofacial surgeon but the variables were examined by student who is blind to use or non-use of mannitol and for this reason this study is blinded both on the patient and the inspector person
Placebo
Not used
Assignment
Parallel
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
Province
Hamadan
Postal code
6541417838741
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.UMSHA.REC.1397.672

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
1,2,4,6
Method of measurement
VAS scale

2

Description
Swelling
Timepoint
2,4,6,8
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
2,4,6,8
Method of measurement
Maximum opening measured between upper and lower incisors

Secondary outcomes

1

Description
Patient satisfaction
Timepoint
8
Method of measurement
Based on planned scale

Intervention groups

1

Description
In this study, side of mandible in which mannitol is infused, 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.
Category
Treatment - Surgery

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
Omid Soltaninia
Street address
Shahid Fahmideh Street, Hamadan City, Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
dentistry@umsha.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Soltaninia
Street address
Hamadan university of medical Sciences,Shahid Fahmideh Street, Hamadan City, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3525 0182
Email
ICT@umsha.ac.ir
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
Omid Soltaninia
Position
Asistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
omid.soltaninia@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Soltaninia
Position
Asistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
omid.soltaninia@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Soltaninia
Position
Asistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Street, Dental School, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
omid.soltaninia@umsha.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after being unidentifiable
When the data will become available and for how long
Starting the access period since 2020
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use of data to advance other similar studies in this field
From where data/document is obtainable
contact to: omid.soltaninia@umsha.ac.ir
What processes are involved for a request to access data/document
The request is checked by the compliance officer and data will be sent if the request is verified
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