The Evaluation of periacryl tissue adhesive effect on the amount of dehiscence after fixation of absorbable membranes in oral surgery for patients of facial surgery faculty of dentistry of Tehran Azad University and private clinic in 2017-2018
Design
This clinical trial study was performed on 30 samples of facial surgery faculty of dentistry of Tehran Azad University and private clinic with indication of alveolar bone remodeling (GBR) with absorbable placement membranes for implant placement and lack of exit criteria.patients are randomly considered as both intervention and control groups.
Settings and conduct
The place of surgery is in faculty of facial surgery at Dentistry Faculty of Tehran Azad University and private clinics. Patients are randomly divided into intervention and control groups. In the control group, the membranes are fixed by suturing, and in the intervention group, the periacryl tissue adhesive is used to fix the membranes. Then both groups will be evaluated for amount of dehiscence after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The Patients who Needed Alveolar Bone Remodeling (GBR) for implant placement
Exclusion criteria: Any risk of systemic disease/ History of bisphosphonate use in the past year/ History of radiotherapy in the jaw area over the past year/ Pregnancy/ History of smoking and alcohol/ History of drug allergies/ The presence of any pathological lesions of soft and hard tissues of the mouth
Intervention groups
Intervention group:Membrane fixation is done by periacryl tissue adhesive
Control group:Membrane fixation is done in a conventional way and through suture
Main outcome variables
In this study, variable; amount of dehiscence is measure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037893N3
Registration date:2018-05-27, 1397/03/06
Registration timing:registered_while_recruiting
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of periacryl tissue adhesive effect on the amount of dehiscence after fixation of absorable membranes in oral surgery
Public title
The Evaluation of periacryl tissue adhesive effect on the amount of dehiscence after fixation of absorable membranes in oral surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients who Needed Alveolar Bone Remodeling (GBR) for implant placement
Exclusion criteria:
Any risk of systemic disease
History of bisphosphonate use in the past year
History of radiotherapy in the jaw area over the past year
Pregnancy
History of smoking and alcohol
History of drug allergies
The presence of any pathological lesions of soft and hard tissues of the mouth
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly considered as both intervention and control groups.Simple random individually with using random numbers
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 Islamic Azad University of Medical Sciences
Street address
No.4, Neyestan10th, Pasdaran street
City
Tehran
Province
Tehran
Postal code
19486
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396/5
Health conditions studied
1
Description of health condition studied
Indication of alveolar bone remodeling (GBR) and implant placement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dehiscence
Timepoint
Dehiscence is examined 1,7,14 and 21 days after surgery
Method of measurement
It is measured by a caliper in millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Membrane fixation is done by periacryl tissue adhesive
Category
Treatment - Other
2
Description
Control group: Membrane fixation is done in a conventional way and through suture
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Street address
Pasdaran street
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 6524 6813
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
2
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Street address
Darband street
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2272 6292
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
No. 4, Neyastan 10th, Pasdaran Street, Tehran
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 6524 6813
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hamid Reza Mahaseni Aghdam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Neyestan 10th, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 6524 6814
Email
H_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, Neyestan 10th, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 6524 6813
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Neyestan 10th, Pasdaran street,Teran
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 6524 6813
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available