The purpose of this study was to investigate the effect of custom made appliance by method of CAD/CAM compared with conventional dressing for reducing facial swelling after maxillofacial surgery. This study was accomplished on 14 patients referred to department oral and maxillofacial surgery at Bahonar hospital in Kerman. Inclusion criteria: patients who have similar bilateral fractures of the upper or lower of jaw; Patients who need orthognathic surgery for similar osteotomy upper or lower jaw. Exclusion criteria: Patients who have asymmetry in their examination; Patient who has a previous history of oral and maxillofacial surgery; Patients with systemic diseases such as diabetes mellitus affecting the healing process and swelling.CT scan of patients was taken to build of custom made appliance. Based on three-dimensional reconstruction custom made appliance was designed and built. Swelling measured before surgery, immediately after surgery, 24 hours, 48 hours and 7 days later. Primary outcome measure was swelling. Secondary outcome measure was type of surgery. Intervention includes type of surgery and type of compression bandage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040427214N1
Registration date:2016-04-22, 1395/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Mohsen Barzegar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3121 5600
Email address
m.barzegar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Abbas Pardakhti
Expected recruitment start date
2014-09-11, 1393/06/20
Expected recruitment end date
2015-07-11, 1394/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of custom made appliance by method of CAD/CAM compared with conventional dressing for reducing facial swelling after maxillofacial surgery
Public title
Efficacy of custom made tool for reducing facial swelling after maxillofacial surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients who have similar bilateral fractures of the upper or lower of jaw; Patients who need surgery for incising soft tissue similar in both sides; Patients who need orthognathic surgery for similar osteotomy upper or lower jaw
Exclusion criteria: Patients who have asymmetry in their examination; Patient who has a previous history of oral and maxillofacial surgery; Patient who has severe damage and unusual soft tissue swelling after trauma; Patients with systemic diseases such as diabetes mellitus affecting the healing process and swelling; Patients who do not have cooperation during the study
Age
From 19 years old to 33 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Somayeh Crossroads
City
Kerman
Postal code
7618759689
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
k/93/541
Health conditions studied
1
Description of health condition studied
facial fracture
ICD-10 code
S02
ICD-10 code description
Fracture of skull and facial bones
Primary outcomes
1
Description
Swelling
Timepoint
Pre operation time,After surgery,1,2 and 7 days after surgery
Method of measurement
Millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Type of compression bandage: custom made appliance and conventional method
Duration 7 days
Appliance is fixed on the patient's face
Category
Other
2
Description
Type of surgery: open treatment and internal fixation in similar bilateral facial fractures and orthognathic surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department Oral and Maxillofacial Surgery at Shahid Bahonar hospital in Kerman
Full name of responsible person
Mohsen Barzegar
Street address
Shahid Bahonar hospital, Gharani Avenue
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Somayeh Crossroad
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?