Determining the symptoms and radiographic success of implant in two techniques of osteodensification and open sinus lift in the resorbed bone of the posterior maxilla
Design
A randomized triple-blind clinical trial with a control group. The study design includes two parallel groups in the 3rd phase each including 10 patients. According to the table of random numbers, patients are classified into two groups.
Settings and conduct
This study will be conducted in the Department of Maxillofacial Surgery, Kerman Dental School. Patients who are candidates for sinus lift will be randomly divided into two groups: open sinus lift and osteodensification. The study will not be blinded. The primary outcome variable will be implant success.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. The bone height in the posterior maxilla in the areas requiring implants should be about 5 mm
2. At least 2 implants should be required in the posterior maxilla for tooth reconstruction.
3. Informed consent to participate in the research project
4. CBCT and OPG of the posterior maxilla for complete bone examination
5. The maxillary ridge bone should be D3 or D4 with low density
Exclusion criteria
1. The patient should be over 60 years of age or not inclined to have dental implants.
2. The patient should have systemic problems and be on medication.
3. The bone width should be insufficient and require simultaneous ridge width reconstruction surgery.
4. The sinus floor bone should be very thick and dense
Intervention groups
Patients will be divided into two groups, one group will undergo open sinus lift surgery and the other group will undergo sinus lift surgery with osteodensification.
Main outcome variables
The main variables studied include implant success and peri-implant bone height. These variables will be measured preoperatively and at 3 and 6 months postoperatively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240517061819N3
Registration date:2025-09-18, 1404/06/27
Registration timing:registered_while_recruiting
Last update:2025-09-18, 1404/06/27
Update count:0
Registration date
2025-09-18, 1404/06/27
Registrant information
Name
Ali Labafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3551 1852
Email address
a.labafchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic investigation of implant success in osseodensification versus open sinus lift in atrophic posterior maxillary bone
Public title
implant success in osseodensification versus open sinus lift
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The bone height about 5 mm
Maxillary ridge bone D3 or D4 with low density
At least 2 implants are required in the posterior maxilla to restore teeth.
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method by one of the nurses of the relevant ward, who is not aware of the implementation of the study. Random sequences will be generated using the Random Generator program. Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process.
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
Kerman University of Medical Sciences
Street address
University campus, Haftbagh Square, shahab st.
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-12-23, 1403/10/03
Ethics committee reference number
IR.KMU.REC.1403.458
Health conditions studied
1
Description of health condition studied
resorbed alveolar bone
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Marginal bone sound
Timepoint
Immediately after implant placement, 3 and 6 months later
Method of measurement
By Ostell device
Secondary outcomes
empty
Intervention groups
1
Description
Control group: an open sinus lift surgery
Category
Treatment - Surgery
2
Description
Intervention group: Using the osteodensification technique
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
dental school, kerman
Full name of responsible person
faeze javaheri
Street address
Bahonar hospital, Gharani st.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kianooshmobasseri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abedin Iranpour
Street address
University of Medical Sciences campus, Haft Bagh Alavi Blvd., Kerman,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
faeze javaheri
Position
Postgraduates student
Latest degree
Medical doctor
Other areas of specialty/work
Oral & maxillofacial surgery
Street address
NO10. Neshat st. Kerman, iran
City
Kerman
Province
Kerman
Postal code
123456789
Phone
+98 51 3551 1852
Fax
Email
faezejavaheri2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
faeze javaheri
Position
Postgraduates student
Latest degree
Medical doctor
Other areas of specialty/work
Oral & maxillofacial surgery
Street address
NO10. Neshat st. Kerman, iran
City
Kerman
Province
Kerman
Postal code
123456789
Phone
+98 51 3551 1852
Fax
Email
faezejavaheri2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
faeze javaheri
Position
Postgraduates student
Latest degree
Medical doctor
Other areas of specialty/work
Oral & maxillofacial surgery
Street address
NO10. Neshat st. Kerman, iran
City
Kerman
Province
Kerman
Postal code
123456789
Phone
+98 51 3551 1852
Fax
Email
faezejavaheri2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data would be shared for all researchers after the participants were unidentified
When the data will become available and for how long
Access to data will start 6 months after publication
To whom data/document is available
The data would only be available for people working in academic institutions
Under which criteria data/document could be used
Data can be used for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email from the corresponding research
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission