Comparison of clinical and radiographic results of crestal sinus lift surgery with and without digital surgical guide on the posterior maxillary edentulous patient whom need sinus lift surgery
Design
Randomized clinical trial single blind
The method of randomization through coding in envelopes
Settings and conduct
This clinical trial will be done in implant department of islamic azad dental school.
Randomization would be through numbering in envelopes
The radiologist who measure radiographic parameters and statistics specialist are blind
Crestal sinus lift and implant placement are performed in patients using non-digital digital methods
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Partially edentulous in premollar and molar teeth, min 4 mm and max 7 mm vertical bone height
Exclusion Criteria:Absence of systemic disease that contraindication for surgery
Intervention groups
First group: conventional implant surgery and sinus lift surgery with osteotome and mallet
Second group: guided flap less implant and sinus lift surgery
Main outcome variables
Surgical procedure time،sinus membrane perforation،post surgical pain،crestal bone changes،sinus floor bone modeling،implants position
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230529058333N1
Registration date:2023-06-28, 1402/04/07
Registration timing:prospective
Last update:2023-06-28, 1402/04/07
Update count:0
Registration date
2023-06-28, 1402/04/07
Registrant information
Name
Mahsa Enssi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5446
Email address
mahsa.enssi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of radiographic and clinical results of crestal sinus lift surgery with and without digital surgical guide
Public title
Comparison of clinical and radiographic results of crestal sinus lift surgery with and without digital surgical guide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Partial maxillary edentulous in molar or premolar region
Available residual bone height from the alveolar crest to the sinus floor, ranging from 4 to 7 mm
Available residual width 6 mm
Priodontal heath ( lack of bleeding on probing- Olery plaque index less than 25%)
Exclusion criteria:
Systemic and local conditions incompatible with implant placement and sinus floor
Active infection in surgical site or adjacent teeth
Acute sinusitis,present of big pathologic o cystic lesion
Under 20 years old
Alcohol and drug abuse
Pregnancy
History of chemotherapy and head&neck radiotherapy in 2 years past
Lack of vertical dimension
Oblique maxillary sinus floor (<45 degree)
Smoking more 10 cigarettes per day
Avoid of signing consent letter
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The radiologist who measure radiographic parameters and statistics specialist are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic azad university of Medical Sciences
Street address
No 4, Neyestan 9th Ave,Pasdaran Ave,Tehran province
City
Tehran
Province
Tehran
Postal code
1946853315
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.IAU.DENTAL.REC.1401.023
Health conditions studied
1
Description of health condition studied
Crestal sinus lift surgery with digital surgical guide، Crestal sinus lift surgery without digital surgical guide
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Primary outcome: Crestal Bone Changes
Timepoint
After Surgery And After 6 Months
Method of measurement
Parallel Periapical Radiograph
2
Description
Primary outcome: Implant Angulation And Implant Distance
Timepoint
6 Months After Surgery
Method of measurement
Cone Beam Computed Tomography
3
Description
Primary outcome: Maxillary Sinus Bone Formation
Timepoint
6 Months After Surgery
Method of measurement
Cone Beam Computed Tomography
4
Description
Secondary outcome: Surgical Procedure Time
Timepoint
During Surgery
Method of measurement
Minutes, With Watch
5
Description
Secondary outcome: Post Surgery Pain
Timepoint
One Week After Surgery
Method of measurement
Pain Killers Number
6
Description
Secondary outcome: Membrane Perforation
Timepoint
During Surgery
Method of measurement
Valsalva Maneuver
Secondary outcomes
empty
Intervention groups
1
Description
Crestal sinus lift surgery with Osteotome and Mallet
Category
Treatment - Surgery
2
Description
Crestal sinus lift surgery with surgical guide And sinus lift kit
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic azad university dental school
Full name of responsible person
Mohammadrza Karimi
Street address
No 9, 9th neyestan,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
m.karimi@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammadreza Karimi
Street address
No 4, Neyestan 9th Ave,Pasdaran Ave,Tehran province
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2256 4571
Email
m.karimi@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammadreza Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
No 605, Negin tower, Jahan koodak street, Afrigha blv
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 8877 4746
Email
m.karimi@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammadreza Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
No 605, Negin tower, Jahan Koodak street, Afrigha blv
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 8877 4746
Email
m.karimi@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Enssi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 14, Nasirian Ave., Mohsenian Ave., Kolahdooz St
City
Tehran
Province
Tehran
Postal code
1945984733
Phone
01222585446
Email
mahsa.enssi@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
Not applicable
Title and more details about the data/document
Patients information including the age, gender, pre and post surgery data/ consent form/ report, clinical trial results, and statistics analysis which has been done.
When the data will become available and for how long
It would be accessible after publishing the results.
To whom data/document is available
Researchers and others who involved in the process.
Under which criteria data/document could be used
All data could be useful for other scientific research,
From where data/document is obtainable
Email:
ِDr. Mohamadreza Karimi: M.karimi@iautmu.ac.ir
Dr. Mahsa Enssi: mahsa.enssi@gmail.com
What processes are involved for a request to access data/document
It should be inquired through given email addresses and can be sent after one month processing time to whom asked for.