- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353619
All-on-X Stackable Guides for Maxillary Terminal Dentition
All-on-X (Full-arch Implant-supported Rehabilitation) Stackable Surgical Guides for Maxillary Terminal Dentition: a 2-year Retrospective Analysis
Study Overview
Status
Conditions
Detailed Description
This study is a retrospective analysis of data derived from a prospectively maintained clinical database evaluating the clinical performance of maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery protocol with immediate loading.
Consecutive patients presenting with terminal maxillary dentition were treated with a maxillary All-on-6 implant-supported complete fixed dental prosthesis (ISCFDP) using a prosthetically driven digital workflow. Implant planning was performed using three-dimensional imaging and dedicated implant planning software, allowing for virtual determination of implant number, position, angulation, and depth in relation to the planned prosthesis. Stackable surgical guides were designed and fabricated to allow guided bone reduction when indicated, followed by fully guided implant placement.
All implants were placed under local anesthesia using a standardized surgical protocol. Implants achieving a minimum insertion torque of 35 Ncm were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. Occlusal contacts were minimized during the healing phase to reduce functional loading. Patients were followed according to a predefined clinical and radiographic follow-up schedule for a minimum period of two years.
The primary outcome of the study will be implant survival at 6 months after placement. Secondary outcomes will include peri-implant clinical parameters (plaque index, bleeding on probing, and probing depth), marginal bone level changes which will be assessed on standardized periapical radiographs at prosthesis delivery, 1-year, and 2-year follow-up visits, and implant success according to established criteria.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohammed El-Sawy, PhD
- Phone Number: 00201061314522
- Email: Dr_sawy@windowslive.com
Study Contact Backup
- Name: Mohammed T. Khater, PhD
- Phone Number: 00201003854552
- Email: MohamedKhaterdentalsmile1234@gmail.com
Study Locations
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Menoufia
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Shibīn al Kawm, Menoufia, Egypt
- Recruiting
- Faculty of Dentistry
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Contact:
- Mohammed El-Sawy
- Phone Number: 00201061314522
- Email: Dr_sawy@windowslive.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult patients presenting with terminal dentition of the maxillary arch
Rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis
Treatment performed using a fully digital stackable guided surgery workflow
Immediate loading with a provisional fixed prosthesis
Availability of complete clinical and radiographic records
Minimum follow-up period of 2 years
Prosthetic design classified as (Fixed prosthesis) FP-1 or FP-2 according to Misch classification
Exclusion Criteria:
Uncontrolled systemic conditions contraindicating implant surgery
History of head and neck radiotherapy
Presence of untreated periodontal or peri-implant infection at the time of surgery
Incomplete or missing clinical or radiographic records
Cases requiring simultaneous bone grafting procedures
Severe maxillary atrophy (Cawood and Howell Class III-V)
Cases requiring FP-3 prosthetic design
Rehabilitation performed without guided surgery or without immediate loading
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Survival Rate
Time Frame: 6 months after implant placement
|
Implant survival was defined as the presence of the implant in situ without removal for any reason, including biological or mechanical failure.
Survival was assessed clinically and radiographically following implant placement and immediate loading.
|
6 months after implant placement
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohammed El-Sawy, PhD, Menoufia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMNF-002026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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