Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
6 participants
INTERVENTIONAL
2024-02-05
2024-09-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla
NCT05108324
Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants
NCT06031506
Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
NCT04101552
Guided Pterygoid Implant
NCT07016828
Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
NCT06114069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants.
Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides.
Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted.
In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
completely limiting computer generated surgical three-dimensional guide
patients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves.
completely limiting computer generated surgical three-dimensional guide
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to the zygoma anatomy-guided approach classification and previously planned surgery using Cone beam C.T lateral window and sinus foor lifting will be decided to be done or not.
After securing the surgical templates in its proper position, sequential osteotomy drilling will be performed in a steady in and out movement under copious sterile saline irrigation.The drills will be entering the maxilla palatally and puncturing the alveolar crest to reach the buccal side.The drills will be visualized through the bony window created until it reaches the zygomatic bone.Sequential drills with the uses of guided tubes,sleeves and keys will be used to guarantee that the implant have been placed in a fully completely guided manner.Afterwards the zygomatic implants will be placed.
Partially limiting computer generated surgical three-dimensional guide
patients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique.
Partially limiting computer generated surgical three-dimensional guide
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full -thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to zygoma anatomy-guided approach classification and previously planned surgery using cone beam C.T.lateral window and sinus floor lifting will be decided to be done or not.After securing the surgical templates,The first drill only will be used using the guide then it will be removed and the other drills will be completed in a free hand without the use of guide to guarantee that the implant will be placed in partially guided manner.Afterwards the zygomatic implants will be placed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
completely limiting computer generated surgical three-dimensional guide
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to the zygoma anatomy-guided approach classification and previously planned surgery using Cone beam C.T lateral window and sinus foor lifting will be decided to be done or not.
After securing the surgical templates in its proper position, sequential osteotomy drilling will be performed in a steady in and out movement under copious sterile saline irrigation.The drills will be entering the maxilla palatally and puncturing the alveolar crest to reach the buccal side.The drills will be visualized through the bony window created until it reaches the zygomatic bone.Sequential drills with the uses of guided tubes,sleeves and keys will be used to guarantee that the implant have been placed in a fully completely guided manner.Afterwards the zygomatic implants will be placed.
Partially limiting computer generated surgical three-dimensional guide
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full -thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to zygoma anatomy-guided approach classification and previously planned surgery using cone beam C.T.lateral window and sinus floor lifting will be decided to be done or not.After securing the surgical templates,The first drill only will be used using the guide then it will be removed and the other drills will be completed in a free hand without the use of guide to guarantee that the implant will be placed in partially guided manner.Afterwards the zygomatic implants will be placed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).
Exclusion Criteria
2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
4. Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fayoum University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Kamal Hassan Ghallab
Teaching assistant in the Department of Oral and Maxillofacial Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fayoum university
Al Fayyum, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Zygomatic Implant
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.