This research is done on patients referring to periodontology and implant ward of the Azad University of Dentistry ,Tehran branch who need implant in maxillary ridge. Samples have adequate bone height but inadequate buccolingual width (width less than 4 mm, minimum 2 mm) that are evaluated with CBCT. Patients who have systemic conditions are excluded. After local anesthesia , a paracrestal incision with two vertical incisions in horizontal endings is made so that two teeth are beyond the area. Full thickness flap is reflected, then buccolingual thickness is measured clinically in 2 and 5 millimeters from crest tip with bone caliper. After buccal bone decortication, mineralized corticocancellous allograft blocks (size 5*10*10 mm) made by HAMANANDSAZ BAFT KISH COMPANY are fixed with 1.4 mm diameter screw and any gap is filled with bone particles and measures are repeated ,then site is covered with collage nous membrane and tension free flap is sutured .Six months after augmentation , measures are repeated. According to the ridge in implant site ,biopsy sample is removed with 2mm trephine drill and sent for histologic evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408173720N3
Registration date:2015-05-03, 1394/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Roya Shariatmadarahmadi
Name of organization / entity
Department of periodontology, Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
r_shariatmadari@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
HAMANANDSAZ BAFT KISH COMPANY
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and histologic evaluation of mineralized corticocancellous allograft blocks for horizontal augmentation of maxillary deficient ridge
Public title
Clinical and histologic evaluation of mineralized corticocancellous allograft blocks for horizontal augmentation of maxillary deficient ridge
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:all patients need augmentation followed by implant treatment. All samples should have adequate bone height but inadequate bucolingual thickness ( width less than 4 mm with minimum width 2mm) that are measured by CBCT.
Exclusion criteria: patients who have systemic conditions affecting healing such as uncontrolled diabetes , immune disorders , systemic or local bone disorders ,previous history of alcohol or drug abuse,smoking,pregnancy,lactating, using immune suppressing agents and anti coagulant agents,poor compliance patients,untreated active periodontal disease and patients who can not keep good oral hygiene or unwillingness to cooperate.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Unit of Azad university of Dentistry ,Tehran branch
Street address
10 th neyestan , pasdaran St
City
Tehran
Postal code
19486
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
12441215
Health conditions studied
1
Description of health condition studied
Horizontal augmentation of maxillary deficient ridge
ICD-10 code
k08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Determination of histologic and clinical effect of mineralized corticocancellous allograft blocks for horizontal ridge augmentation in maxilla
Timepoint
Six months
Method of measurement
CBCT and bone caliper
Secondary outcomes
empty
Intervention groups
1
Description
Horizontal augmentation of maxillary ridge
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad university of Tehran , Dental branch
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamanand saz baft kish company
Full name of responsible person
Mr. Kaveh
Street address
No.8, Eastern 19th , saadat abad St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamanand saz baft kish company
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
Department of Periodontology ,Dental branch,Islamic Azad University of tehran
Full name of responsible person
Roya Shariatmadar ahmadi
Position
Periodontist
Other areas of specialty/work
Street address
No 4,9th neyestan,pasdaran St
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
dr.r.shariatmadari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of periodontology,Dental branch,Islamic Azad university of tehran
Full name of responsible person
Roya shariatmadarahmadi
Position
Periodontist
Other areas of specialty/work
Street address
No 4,9 th neyestan,pasdaran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
dr.r.shariatmadari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental branch,Islamic Azad univercity
Full name of responsible person
Babak Iranpour
Position
Post graduate student
Other areas of specialty/work
Street address
No.4.10th Neyestan,pasdaran
City
Tehran
Postal code
19486
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
Iranpour1391@gmail.com
Web page address
www.Dental.Iau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)