Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301774017220 Date of Approval: 26/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Magnetic Mallet Versus Piezotome In Crestal Window Maxillary Sinus Augmentation Followed By Delayed Implant Placement (Randomized Controlled Clinical Trial)
Official scientific title Comparison of Magnetic Mallet Versus Piezotome In Crestal Window Maxillary Sinus Augmentation Followed By Delayed Implant Placement (Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Sinus pneumatization is a continuous physiological process that occurs naturally and causes an increase in paranasal sinus’ volume. Such pneumatization is also commonly observed following extraction of posterior maxillary teeth which is sometimes referred to as “disuse atrophy”. Sinus augmentation has been shown to be an effective methodology to augment a deficient maxillary sinus. However, there are many techniques a clinician can choose from. Sinus augmentation techniques include lateral window and transalveolar sinus lift with or without bone grafts. The Crestal Window Approach for Sinus Floor Grafting is a technique which combine the ease of accessibility and low morbidity of the crestal approach with the direct visualization of Schneiderian membrane and high capacity of vertical sinus floor augmentation of the lateral approach. In 2001, Vercellotti described a new procedure for sinus elevation using an ultrasonic surgical technique that simplifies maxillary sinus surgery using the piezoelectric bony window osteotomy. The elevation of the membrane from the sinus floor was performed using both piezoelectric elevators and the pressure of a physiologic solution subjected to piezoelectric cavitation. The aim of this study is to compare the efficiency of magnetic mallet versus piezotome for crestal window sinus floor elevation technique in treatment of extremely atrophic posterior maxilla.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnetic mallet N/A 6 months Crestal window sinus lifting using magnetic mallet 10
Control Group Pizotome N/A 6 months Crestal window sinus lifting using Pizotome 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with missing posterior maxillary molars. Vertical bone height of 2-3 mm. horizontal bone width not less than 6 mm Good oral hygiene. Acute maxillary sinusitis. Presence of infection or periapical lesions in adjacent teeth. Bruxism or clenching. Alcohol intake. Medically compromised patients with medical conditions contraindicating elective dental surgery. Multiple septa in the maxillary sinus. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2022 The Ethics Committee of the Faculty of Dentisry Alexandria University IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bone density of the newly formed bone 6 months postoperative
Secondary Outcome Operative time Intraoperative
Secondary Outcome Incidence of sinus membrane perforation Intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Alexandria University Teaching Hospital and operated in the Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Faculty of Dentistry Champollion Street - Azarita. Alexandria, Egypt Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marwan Mohamed Elsaid 349 Gamal Abd El-Nasir street Alexandria 21539 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champollion St., El Messalah, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwan Mohamed Elsayed 349 gamal abd el naser street Alexandria 21539 Egypt
Lydia Nabil Fouad Melek 19 el Fath street Sidi Beshr Alexandria 21611 Egypt
Magda Mohammed Saleh 14 El-Shaheed Kamal El-Deen Salah Alexandria 21648 Egypt
Saeeda Mahmoud Osman 2 Albert first street Smouha Alexandria 21648 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Lydia Melek lydia.nabil@dent.alex.edu.eg 00201224807468 19 el Fath street Sidi Beshr
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt Associate Professor of Oral And Maxillofacial Surgery Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Principal Investigator Saeeda Osman Saeeda.osman.dent@alex.edu.eg 00201227391889 2 Albert first street Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Professor of Oral And Maxillofacial Surgery Faculty of Dentistry Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information