The aim of this study was to evaluate the radiographic results of the Vertical Expander Screw method for trans alveolar elevating of maxillary sinus: A Single Arm Trial
Design
This is a non-control, double-blind, randomized, clinical trial on 22 patients. Excel software rand function was used for randomization.
Settings and conduct
In this method, using Bone Management Kit (Microdent® ) and using special screws for bone spreading, we will start to expand the bone to the appropriate height and also a drill with a diameter less than the last drill of the relevant implant system to place the appropriate implant. By performing this step, the sinus membrane will be raised.This study will be performed in the periodontics department of Shahid Beheshti Dental School.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the need to place implants in the posterior areas of the maxilla; Need to treat sinus lift in a closed manner.
Exclusion criteria: Patients who smoke, inadequate hygiene and the presence of systemic disease with the use of medications that affect bone metabolism
Intervention groups
Intervention group: In 22 patients, sinus lift is performed by VEST method.
Main outcome variables
Evaluation of marginal bone loss (MBL) 6 months after surgery using parallel periapical radiography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190712044177N3
Registration date:2022-04-12, 1401/01/23
Registration timing:registered_while_recruiting
Last update:2022-04-12, 1401/01/23
Update count:0
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Mahdi Kadkhodazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 2208
Email address
mahdi.sbmu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic assessment of a conservative approach by using the expander screws for tran-salveolar
Public title
sinus lift
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
21 years of age
partial edentulism of the97 posterior maxilla
sufficient bone width
no maxillary sinus pathologies
a minimum of 5-7 residual bone height
the O’Leary’s plaque index20%
achieving adequate primary stability following implant placement.
Exclusion criteria:
poor oral hygiene or lack of regular maintenance
systemic diseases or intake of medications known to affect bone metabolism
contraindications for sinus floor elevation
the presence of parafunctional habits such as bruxism or clenching
Smoking
Age
From 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for patient care, data collectors, and those who evaluate the outcome are unaware of the surgical procedure used. .
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Department of Periodontics, School of Dentistry, Shahid Beheshti University of Medical Sciencesو Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-01-04, 1400/10/14
Ethics committee reference number
IR.SBMU.DRC.REC.1400.090
Health conditions studied
1
Description of health condition studied
Maxillary Sinus Pneumatization
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Marginal Bone Loss
Timepoint
pre0prative and 6 month later
Method of measurement
Periapical Radiographic Evaluation
2
Description
Endo-sinus Bone Gain
Timepoint
6 month after surgery
Method of measurement
Periapical Radiographic Evaluation
Secondary outcomes
1
Description
Pain
Timepoint
Post-operative and 1 week later
Method of measurement
Visual Analogue scale from 0 to 10
2
Description
post-operative complication
Timepoint
Post-operative and 6 month later
Method of measurement
Number of cases with membrane perforation, Implant failure and Infection by Clinical evaluation
Intervention groups
1
Description
Intervention group: Drilling was performed with a starter 128drill (800 rpm) to 1 mm distance from the maxillary sinus 129floor. Then, the first non-traumatic threaded expander 130(Microdent, Spain) was applied into the prepared osteot- 131omy site (Fig. 1). The expansion was continued superiorly 132to reach the cortical bone and push the sinus floor up with 133dome shaped ends. The desired height for the intended 134implant was achieved by gradually increasing the diameter 135of the expander screws. This process was continued until 136the appropriate osteotomy size was created. The penulti- 137mate drill (corresponding to the drill diameter of the 138selected implant system) was subsequently used to the 139bone level height in order to remove the probably highly 140compressed layer.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences