The aim of the present study is to evaluate the applicability of the fibrin glue in the closure of the nasal mucosa in alveolar cleft patients. This clinical trial would be conducted on patients of 9 years old and more referring to Al-Zahra Hospital during spring and summer of the present year (2011). A total of 15 consecutive patients who meet the inclusion criteria and sign the informed consent sheets would be placed in the intervention or control groups. Standard protocol of surgical bone grafting would be performed in the control group. Similar steps will be done for the patients in the intervention group except for the closure of the nasal mucosa which is accomplished with the aid of fibrin glue instead of standard suturing. The operating time, incidence of postoperative complications such as infection and wound dehicense, alveolar height at the grafted site will be measured in each group and results will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103055972N1
Registration date:2011-06-30, 1390/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Bijan Movahedian
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2854
Email address
b_movahedian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-04-01, 1390/01/12
Expected recruitment end date
2011-11-01, 1390/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Applicability of Fibrin Glue in closure of nasal mucosa in bone grafting of alveolar clefts
Public title
Applicability of Fibrin Glue in closure of nasal mucosa in bone grafting of alveolar clefts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 9 years old and more, no systemic disease, no previous surgical treatment of the same problem, unilateral alveolar cleft, complete mental health
Exclusion criteria: less than 9 years old, any previous bone grafting in the cleft area, any systemic disease, bilateral alveolar cleft, any mental or cognitive disease
Age
From 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Isfahan University Of Medical sciences
Street address
Hezar Jarib Avenue
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
188127
Health conditions studied
1
Description of health condition studied
Alveolar cleft
ICD-10 code
Q35.1, Q37
ICD-10 code description
Cleft hard palate, Unspecified cleft palate with bilateral cleft lip, Unspecified cleft palate with unilateral cleft lip
Primary outcomes
1
Description
Bone healing in graft area
Timepoint
1 and 3 months after operation
Method of measurement
radiographic and clinical examination
2
Description
duration of the procedure
Timepoint
At the end of the surgery
Method of measurement
timer ( minute)
Secondary outcomes
1
Description
incidence of post operative infection
Timepoint
during the 3-months healing time period
Method of measurement
clinical observation
2
Description
incidence of postoperative wound dehicence
Timepoint
during the 3-months period of healing phase
Method of measurement
clinical observation
Intervention groups
1
Description
Intervention group: standard surgical treatment with an exception of closure of the nasal mucosa with fibrin glue instead of standard suturing technique
Category
Treatment - Surgery
2
Description
Control group: standard surgical treatment including the closure of the nasal mucosa with sutures
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Zahra Fallah, GP, Research Assistant
Street address
Vice-Chancellery for Research(bldg no.4) ,Isfahan University of medical sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Associate professor, department of maxillofacial surgery
Other areas of specialty/work
Street address
Isfahan dental school,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2854
Fax
Email
b_movahedian@dnt.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Associate professor, department of maxiloofacxoal surgery,Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan dental school, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2854
Fax
Email
b_movahedian@dnt.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Associate professor, department of maxillofacial surgeryIsfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan dental school,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2854
Fax
Email
b_movahedian@dnt.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)