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.: PACTR202408754632183 Date of Approval: 02/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of Guided Lateral Maxillary Sinus Lift Procedure with Simultaneous Implant Placement Using Stereolithographic Surgical Guide
Official scientific title Assessment of Guided Lateral Maxillary Sinus Lift Procedure with Simultaneous Implant Placement Using Stereolithographic Surgical Guide
Brief summary describing the background and objectives of the trial The proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure. Clinical evidence also shows that in the case of the minimum residual alveolar bone height, simultaneous implant placement and open sinus elevation is a viable treatment modality without compromising the primary stability of the implant. However, compared to the two-stage approach, preparing an osteotomy during one stage sinus floor elevation without disturbing the sinus membrane is technique sensitive and challenging. The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery. The use of three-dimensional printing technology can reproduce the patient bone anatomy into a physical model, as well as precise surgical templates and guides. The aim of this study is to assess the efficacy of the stereolithographic surgical guide in reducing intraoperative and postoperative complication during lateral sinus lift operation.
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: Surgery
Anticipated trial start date 23/01/2022
Actual trial start date 23/01/2022
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 20/11/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Freehand Lateral Window Osteotomy 6 months follow up Lateral window was done conventionally (freehand) for placement of 15 implants in posterior edentulous maxillary regions. 15 Active-Treatment of Control Group
Experimental Group Guided Lateral window osteotomy 6 months Lateral window was done using stereolithographic surgical guide for placement of 15 implants in posterior edentulous maxillary regions. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Males and females ≥ 18 years of age. • ASA I and ASA II. • Patients having partial edentulism in the posterior region of the maxilla. • Edentulous sites consist of native non augmented bone. • Horizontal ridge dimension minimum of 5mm • The vertical ridge dimension 4-7 mm. • Bone quality of D2 or D3. • Enough inter-arch distance. • Patients with active acute infection or residual lesion related to the edentulous sites. • Acute maxillary sinus pathosis • Remaining root dislodged in the Maxillary sinus. • Patients that lack a stable occlusion or have parafunctional habits. • Patients with poor oral hygiene who are not amenable to motivation and improvement. • Smokers who smoke more than 10 cigarettes a day. • Pregnant or lactating mothers. • Alcohol and drug abuse. • Treatment with radiation therapy in the craniofacial region within the previous 12 months. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 21/12/2021 Suez Canal Ethical Committee
Ethics Committee Address
Street address City Postal code Country
4.5 Km Ring Road, Ismailia, Egypt ismailia 8366004 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence or absence of intra or postoperative complications - Schneiderian membrane perforation occurrence, intraoperative bleeding, epistaxis, postoperative sinusitis, periimplantitis intraoperative and postoperative
Secondary Outcome Postoperative pain everyday for 10 days
Secondary Outcome Postoperative edema preoperative, 3 days postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oral and Maxillofacial Surgery Department Faculty of Dentistry Suez Canal University 4.5 Km Ring Road, Ismailia, Egypt Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Wael Alaaeldin Hussein Villa 9, Axis 82, 5th Settlement, 5th District, Area 1, New Cairo Cairo 11835 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wael Alaaeldin Hussein Villa 9, Axis 82, New Cairo Cairo 11835 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Hussein wael.alaa@miuegypt.edu.eg +201101140008 Villa 9, Axis 82, 5th Settelement, 5th District, Area 1, New Cairo
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Assistant Lecturer Oral and Maxillofacial Surgery Misr International University
Role Name Email Phone Street address
Public Enquiries Wael Hussein wael.alaa@miuegypt.edu.eg +201140008022 Villa 9, Axis 82, New Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer Misr International University
Role Name Email Phone Street address
Scientific Enquiries Wael Hussein wael.alaa@miuegypt.edu.eg +201140008022 Villa 9, Axis 82, New Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer Misr International University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in stereolithographic surgical guide in lateral window osteotomy. Data or samples shared will be coded, with no PHI included. Informed Consent Form 2 years Controlled for researchers only with a third party to decide
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information