Evluating the effect of using collagen membrane over the osteotomy window on newly formed bone and connective tissue in comparison with not using collagen membrane in lateral sinus lift surgery.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized.
Settings and conduct
30 patients who required maxillary lateral sinus lift and referred to Mashhad Dental School, were evaluated and they were selected for this study.the patients were randomly allocated to control group(membrane) or test group(no membrane).after 6 months, they underwent the second surgery for implant placement. During implant placement, a bone biopsy was removed from the area where the implant was to be inserted and they were sent to the histological laboratory for histological evaluation. After evaluating the quality of histologic slices, newly formed bone and the connective tissue was examined with Image J software, the study was a double-blind study with a blind pathologist analyzing and blind pathologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:residual bone height 3 to 5 mm, good oral hygiene.
Non inclusion criteria:head and neck radiotherapy, uncontrolled diabetes, pregnancy, pathologic lesion or sinus disease, uncontrolled periodontal disease, chemotherapy in the last 12 months before surgery.
Intervention groups
In control group, the bone window was covered with collagen membrane. In intervention group, the bone window wasnt covered with collagen membrane.
Main outcome variables
Measured variables include the amount of newly formed bone and connective tissue.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200125046247N1
Registration date:2020-02-15, 1398/11/26
Registration timing:retrospective
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
negin jabbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3602 7437
Email address
negin.jb73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-11-24, 1397/09/03
Actual recruitment end date
2019-06-19, 1398/03/29
Trial completion date
2019-06-19, 1398/03/29
Scientific title
Evaluation the use of collagen membranes on the osteotomy window in the open sinus lift approach.
Public title
Evaluation of the use of collagen membranes in comparison with non-use of membranes in sinus floor surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The remaining bone height is 3 to 5 mm.
Good oral hygiene.
Exclusion criteria:
Radiotherapy in the head and neck area.
Uncontrolled diabetes.
Pregnancy.
Pathological lesion or sinus disease.
Uncontrolled periodontal disease.
History of chemotherapy in the last 12 months before surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is based on random number table.
Randomization type: Simple randomization.This method uses simple randomization models such as tap or line, use of random numbers table or computer randomization methods, and each client for example with throws coin, tap and line,put it in the intervention or control group or It is very simple to implement.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study.
Statistical analyst and pathologist evaluator were blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad Dental School Ethics Committee
Street address
Faculty of Dentistry,opposite mellat park,vakilabad blv,mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.099
Health conditions studied
1
Description of health condition studied
Study on Maxillary Sinus Lift Surgery.
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
The amount of newly formed bone in patients undergoing sinus lift surgery.
Timepoint
Measurement of newly formed bone is performed 6 months after sinus lift surgery and at implant placement time.
Method of measurement
The amount of newly formed bone in each slide was calculated by the image j software. It gives a number that specifies the surface area of each slide. Finally, the number obtained for each patient that represents the amount of newly formed bone is entered into the Statistical Package for Social Sciences(spss)software.
2
Description
The amount of connective tissue in patients undergoing sinus lift surgery.
Timepoint
Measurement of connective tissue is performed 6 months after sinus lift surgery and at implant placement time.
Method of measurement
The amount of connective tissue in each slide was calculated by image j software. It gives us a number that specifies the surface area of each slide. Finally, the numbers obtained for each patient indicating the amount of connective tissue are entered into the Statistical Package for Social Sciences(spss) software.
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" No collagen membrane use over the bone window in open sinus lift surgery. at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place and Without covering the bone window by the membrane, the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture.
Category
Other
2
Description
"Control group:" Use of absorbed collagen membrane with a diameter of 0.2–0.4 mm over the bone window in open sinus lift surgery. at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place.the bone window was covered with collagen membrane, then the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Doctor Mojgan Kazemian
Street address
Faculty of Dentistry,opposite mellat park,vakilabad blv,mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
jabbarin921@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Amin Rahpeyma
Street address
Faculty of Dentistry,opposite Mellat Park,Vakilabad Boulevard,Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
jabbarin921@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
30
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
Mashhad University of Medical Sciences
Full name of responsible person
Negin Jabbari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Number 54-14th gooya,gooya street,malekabad blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9186654773
Phone
+98 51 3602 7437
Fax
Email
negin.jb73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mojgan Kazemian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,opposite Mellat Park, Vakilabad Boulevard,Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 915 515 7022
Email
kazemianmz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negin Jabbari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Number 54-14th gooya,gooya street,malekabad blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9186654773
Phone
+98 51 3602 7437
Fax
Email
negin.jb73@gmail.com
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