Protocol summary

Study aim
Clinical comparison of sinus lift surgery via piezosurgery and usual rotary techniques
Design
In order to make a better clinical comparison and eliminate intervening variables such as age and gender, both sinus lift surgery methods are performed for a specific patient with bilateral posterior areas who have no teeth; Therefore, each patient is considered his own control. Randomization was done with Excel software and the sample size is 22 people, also the trial is one_side blinded
Settings and conduct
Patients get the same and standard antibioftic therapies and analgesics and also the same implant system is used on both sides. The corresponding maxillofacial surgeon is a single person and the examinations of the second stage of the surgery are performed by another person, blindly. The surgical method is performed as a lateral_wall approach sinus lift and the minimum vertical height of the bone should be 5mm so that it is possible to place the implant simultaneously with the sinus lift. In the next steps, post-surgery evaluations are done. The place where interventions are done, is also a private office.
Participants/Inclusion and exclusion criteria
Over 18 years old, systematically healthy, Needing bilateral sinus lift and implant for the posterior areas of maxilla; immune system defect, infection in poterior areas of maxilla, sinusitis, needing advanced bone surgery or transverse ridge augmentation, destructive parafunctional habit, pregnant or lactating women.
Intervention groups
Sinus lift surgery, which is examined in this study, is performed by two interventional methods, including piezosurgery and surgery with conventional rotary devices. In this study, both surgical methods are performed on the same person. In fact, each person is considered a control sample for himself and comparison is made.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221209056759N1
Registration date: 2023-01-08, 1401/10/18
Registration timing: registered_while_recruiting

Last update: 2023-01-08, 1401/10/18
Update count: 0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Hadi Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4645
Email address
hadi.mohammadi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-02, 1401/08/11
Expected recruitment end date
2023-01-13, 1401/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of sinus lift via piezosurgery and usual rotary techniques especially in terms of the pain after surgery in two sides of a single patient, in people who need bilateral sinus lift and implant in posterior sides of maxilla
Public title
Clinical comparison of sinus lift via piezosurgery and usual rotary techniques
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old Needing bilateral sinus lift and implant for the posterior areas of maxilla Systematically healthy
Exclusion criteria:
Immune system defect Infection in poterior areas of maxilla Sinusitis Needing advanced bone surgery or transverse ridge augmentation Destructive parafunctional habit Pregnant or lactating women
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 22
More than 1 sample in each individual
Number of samples in each individual: 2
Right posterior areas of maxilla and left posterior areas of maxilla from a single patient
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method; It is with quadruple blocks with individual randomization unit. Excel software has also been used for randomization. Concealment has been done in such a way that two independent envelopes are available, one is available to the secretary and the other is available to the surgeon. With each patient's visit, the secretary assigns a row number to the patient based on the order of the visit (after meeting the entry and exit criteria). The surgeon has her own sealed envelope and acts based on it.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before participating in the trial, patients have a complete awareness of reciveing two therapeutic intervention through two surgical methodes; but they do not know that which surgery will be done first and which side (right or left) will get the surgery first.
Placebo
Not used
Assignment
Crossover
Other design features
With the exact design of the study in the form of split-mouth crossover, it is tried to eliminate intervening variables that may have confusing results.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Kurdistan University of medical sciences
Street address
Ethics committe, second floor, medical faculty, Kurdistan medical University, Pasdaran Blvd
City
Sanandaj
Postal code
6617713446
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.MUK.REC.1401.271

Health conditions studied

1

Description of health condition studied
Sinus lift surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
24, 48, 72 hours and 1 week after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Sinus perforation
Timepoint
During the surgery
Method of measurement
Surgeon's observation

2

Description
Time of surgery
Timepoint
During surgery
Method of measurement
Minures

3

Description
Field of view of the surgery
Timepoint
During the surgery
Method of measurement
Four point scale

4

Description
Eating and sleeping
Timepoint
During the week after surgery
Method of measurement
Pittsburgh Sleep Quality Index and a valid questionnaire for Eating changes

Intervention groups

1

Description
Intervention group:Augmentin (Amoxicillin + Clavulanic acid) plus Acetaminophen 500 mg, is prescribed for all patients (three times a day or TDS) from one day before surgery until five days after surgery. On the day of surgery, after getting sufficient anesthesia by infiltration and anesthesia of posterior and middle superior alveolar nerves and also greater palatine nerve, patiant is prepared for surgery. 5 minutes before surgery, the patient keeps chlorhexidine mouthwash in his mouth for one minute. The surgical method is performed as a lateral_wall approach sinus lift. A crustal incision is made in the area of ​​the implant along with a vertical freeing incision in the distal of the flap. the mucoperiosteal flap is lifted. After complete reflection of the mucoperiosteal flap, osteotomy is performed in the lateral wall of the sinus using piezosurgery (US_11 LED piezo bone surgery Woodpecker) or rotary at a speed of 2000 rpm.After elevating the sinus membrane, implant is placed at the same time according to the manufacturer's protocol. Also, after evaluating the surgical site, Allogenous frozen-dried corticocancellous bone chips (from Iranian tissue product co. and particle size 1000-2000 micrometers) and absorbable membrane (from Brand Iranian tissue product co., size 20 x 30 mm and thickness 3. to 4. mm) is placed and the area is sutured with four-zero nylon thread.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Ideh Talimkhani
Street address
No. 33, 6th floor, Molavi medical building, Molavi Ave., Felestin Blvd., Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۶۶۵۳۹۹۲
Phone
+98 87 3322 7825
Email
ideatalimkhani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Kurdistan Province, Sanandaj City, Pasdaran St., below Quds Hospital, Kurdistan University of Medical Sciences Campus, Deputy of research and Technology
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3366 4654
Email
Research@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Ideh Talimkhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
No. 33, 6th floor, Molavi medical building, Molavi Ave., Felestin Blvd., Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۶۶۵۳۹۹۲
Phone
+98 87 3322 7825
Email
ideatalimkhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ideh Talimkhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
No. 33, 6th floor, Molavi medical building, Molavi Ave., Felestin Blvd., Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۶۶۵۳۹۹۲
Phone
+98 87 3322 7825
Email
ideatalimkhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fateme Pooladvand
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
NO. 92, Asgari 5 Ave., Azadi Blvd., Baharestan, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8145135386
Phone
+98 31 3682 8320
Fax
Email
Fatemepooladvand76@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
information gathered from the patients, is collected in the form of a file called sinus lift study data. All patient information can be provided after de-identification.
When the data will become available and for how long
Access will start from the year 1402.
To whom data/document is available
All people who want to access the data are allowed to do so.
Under which criteria data/document could be used
In order to know the information obtained from the patients, they can use the data. The condition of accessing the data requires providing the person's purpose of access and research resume.
From where data/document is obtainable
Applicants can request access to the data from Fateme Pooladvand. Email address: fatemepooladvand76@gmail.com They can also contact Dr. Ideh Talim Khani. Email address: ideatalimkhani@yahoo.com
What processes are involved for a request to access data/document
First, send their desired request. They must comply with the requested conditions and after conducting the necessary checks, this information will be provided to them. Consider the approximate and maximum time of 2 months.
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