To compare the success of maxillary sinus lifting surgery in pathologic sinuses versus normal sinuses
Design
This is a non-randomized, controlled, parallel-group, unblinded clinical trial study in which patients with and without pathological findings on maxillary sinus radiographs will undergo surgery.
Settings and conduct
This study will be conducted at the Hamadan School of Dentistry on 20 dental implant candidates. Patients will be assigned to intervention and control groups based on the presence or absence of increased mucosal thickness in the maxillary sinus on radiographic examination. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Candidates for dental implants
Radiographic view showing increased mucosal thickness in the maxillary sinus (in the intervention group)
Radiographic view showing no increased mucosal thickness in the maxillary sinus (in the control group)
Exclusion criteria:
Presence of acute sinus infection or inflammation
Intervention groups
Intervention group:
Elevation of the floor of the maxillary sinus in the area of the first premolar to the first molar by open surgery in patients with radiographic evidence of increased mucosal thickness in the maxillary sinus
Control group:
Elevation of the floor of the maxillary sinus in the area of the first premolar to the first molar by open surgery in patients without radiographic evidence of increased mucosal thickness in the maxillary sinus
Main outcome variables
Primary outcome:
Measuring the appropriate bone height, Measuring the amount of integrated bone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N553
Registration date:2025-03-21, 1404/01/01
Registration timing:prospective
Last update:2025-03-21, 1404/01/01
Update count:0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-06-10, 1404/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success of maxillary sinus lifting surgery in pathologic sinuses versus normal sinuses: a clinical trial
Public title
Comparison of the success of maxillary sinus lifting surgery in pathologic sinuses versus normal sinuses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Candidates for dental implants
Radiographic view showing increased mucosal thickness in the maxillary sinus (in the intervention group)
Radiographic view showing no increased mucosal thickness in the maxillary sinus (in the control group)
Exclusion criteria:
Presence of acute sinus infection or inflammation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-01-12, 1403/10/23
Ethics committee reference number
IR.UMSHA.REC.1403.642
Health conditions studied
1
Description of health condition studied
Dental implant
ICD-10 code
M27.6
ICD-10 code description
Endosseous dental implant failure
Primary outcomes
1
Description
Measuring the appropriate bone height
Timepoint
6 months after surgery
Method of measurement
Using radiography
2
Description
Measuring the amount of integrated bone formation
Timepoint
6 months after surgery
Method of measurement
Using radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Elevation of the floor of the maxillary sinus in the area of the first premolar to the first molar by open surgery in patients with radiographic evidence of increased mucosal thickness in the maxillary sinus
Category
Treatment - Surgery
2
Description
Control group: Elevation of the floor of the maxillary sinus in the area of the first premolar to the first molar by open surgery in patients without radiographic evidence of increased mucosal thickness in the maxillary sinus
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Negin Esmaeili
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drness81@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Negin Esmaeili
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drness81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Heydari
Position
Maxillofacial Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aliheidari55@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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