In this study, the need for placing a second miniplate as a tension band in presence of lower arch bar is evaluated in mandibular parasymphysis fractures. 90 patients with mandibular parasymphysis fracture will be included in the study. They will be divided into two equal groups randomly. Arch bar will be placed for all patients. Then the first group will be treated with only one miniplate at the inferior border, but the second group will be treated with the same method and an additional miniplate will be placed 4 to 5 milimeters above the first miniplate. A follow-up after 6 months will be performed. The duration of surgery, incidences of occlusal discrepancy, infection, wound dehiscence, sensory changes and exposure of implants will be assessed. Then these parameters will be compared between the two group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052718946N6
Registration date:2017-06-17, 1396/03/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
Reza Piri
Name of organization / entity
Emam Reza educational-medical center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 5372
Email address
reza.piri@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of placement of second miniplates as tension band unit in mandibular parasymphysis fractures
Public title
Placement of second miniplates as tension band
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 65 years old; patients with mandibular parasymphysis fractures; filling written consent; patients with indication of surgical intervention.
Exclusion criteria: patients with accompanying fractures; patients with comorbidities.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah street
City
Tabriz
Postal code
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.TBZMED.REC.1396.96
Health conditions studied
1
Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Lower jaw (bone)
Primary outcomes
1
Description
Surgery duration
Timepoint
day 0
Method of measurement
Clock
2
Description
Occlusal discrepancy
Timepoint
Day 180
Method of measurement
Physical examination
3
Description
Wound infection
Timepoint
Day 180
Method of measurement
Physical examination
4
Description
Wound dehiscence
Timepoint
Day 180
Method of measurement
Physical examination
5
Description
Sensory changes
Timepoint
Day 180
Method of measurement
Physical examination
6
Description
Exposure of implants
Timepoint
Day 180
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: arch bar will be placed for all the patients and they wil be treated with only one miniplate at the inferior border of mandible.
Category
Treatment - Surgery
2
Description
Intervention group: Arch bar will be placed for all patients and group is treated with a miniplate at the inferior border of mandible,then they will be treated with an additional miniplate placed 4 to 5 milimeters above the inferior miniplate.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Yousef Kananizadeh
Street address
Daneshgah street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Central campus of Tabriz University of Medical Sciences, Golgasht street, Azadi avenue. Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Dentistry faculty of Tabriz university of medical sciences
Full name of responsible person
Dr. Yousef Kananizadeh
Position
Resident maxilofacial surgery
Other areas of specialty/work
Street address
Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 914 119 8967
Fax
Email
rzanz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Denstistary faculty of Tabriz university of medical sciences
Full name of responsible person
Dr. Yousef Kananizadeh
Position
Resident of maxilofacial surgery
Other areas of specialty/work
Street address
Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3334 5372
Fax
Email
rzanz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dentistry faculty of Tabriz university of medical sciences
Full name of responsible person
Dr. Yousef Kananizadeh
Position
Resident of maxilofacial surgery
Other areas of specialty/work
Street address
Azadi street, Golgasht avenue
City
Tabriz
Postal code
Phone
+98 41 3334 5372
Fax
Email
rzanz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)