A clinical trial to investigate the effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in single maxillary posterior teeth implants, compared to multiple maxillary posterior teeth implants after sinus lift
To investigate the effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in single with multiple maxillary posterior teeth implants after sinus lift
Design
Totally, 40 patients undergoing dental implants treatment in the Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran are selected in this study. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods.
Settings and conduct
Patients whose undergoing dental implants treatment and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged range of 20-50 years; patients candidate for maxillary posterior teeth implants with a minimum of 2-4 mm alveolar bone thickness according to CBCT with a need for the sinus lift.
Exclusion criteria: The presence of systemic diseases; patients who cannot undergo routine oral surgery; patients who smoke more than 10 cigarettes daily; the presence of sinusitis; pregnant and breastfeeding women; history of allergies; membrane perforations more than 2 mm.
Intervention groups
Intervention group I will receive sinus lift surgery for single posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 5 bony walls. Intervention group II will receive sinus lift surgery for multiple posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 3 bony walls.
Main outcome variables
Evaluation and comparison of the bone mineral density formed, rate of angiogenesis, number of osteoblasts per unit area and implant stability in the bone graft
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210204050239N1
Registration date:2021-02-07, 1399/11/19
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Mehran Farhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
gholamimh1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to investigate the effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in single maxillary posterior teeth implants, compared to multiple maxillary posterior teeth implants after sinus lift
Public title
The effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in dental implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged range of 20-50 years
Patients candidate for maxillary posterior teeth implants with a minimum of 2-4 mm alveolar bone thickness according to CBCT with a need for the sinus lift
Exclusion criteria:
The presence of systemic diseases
Patients who cannot undergo routine oral surgery
Patients who smoke more than 10 cigarettes daily
The presence of sinusitis
Pregnant and breastfeeding women
History of allergies
Membrane perforations more than 2 mm
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing dental implants treatment and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.070
Health conditions studied
1
Description of health condition studied
Teeth implants
ICD-10 code
Z96.8
ICD-10 code description
Presence of other specified functional implants
Primary outcomes
1
Description
The bone mineral density formed
Timepoint
6 months after the intervention
Method of measurement
Cone beam computed tomography
2
Description
The rate of angiogenesis
Timepoint
6 months after the intervention
Method of measurement
Histological osteogenesis with hematoxylin-eosin staining
3
Description
Number of osteoblasts per unit area
Timepoint
6 months after the intervention
Method of measurement
Histological osteogenesis with hematoxylin-eosin staining
Secondary outcomes
1
Description
Implant stability in the bone graft
Timepoint
Immediately and 4 months after the intervention
Method of measurement
Osstell Mentor
Intervention groups
1
Description
Intervention group: Intervention group I will receive sinus lift surgery for single posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 5 bony walls (medial, lateral, mesial, distal, and inferior).
Category
Treatment - Surgery
2
Description
Intervention group: Intervention group II will receive sinus lift surgery for multiple posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 3 bony walls (medial, lateral, and inferior).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Mehran Farhadi
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Mehran.farhaadi74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@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
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
Mashhad University of Medical Sciences
Full name of responsible person
Mehran Farhadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Mehran.farhaadi74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehran Farhadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Mehran.farhaadi74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehran Farhadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Mehran.farhaadi74@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Mehran Farhadi the data analysis to the applicants via email: Mehran.farhaadi74@gmail.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week