- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556330
Computer Guided Versus Free Hand Horizontal Ridge Augmentation in Anterior Mandible.
September 23, 2022 updated by: Mohamed Ibrahim Ahmed Sakr, Cairo University
Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial
Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique:
randomized clinical trial
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
patients with deficient anterior mandible were included in this study where control group patients received free hand harvesting and fixation of cortical shells from the symphysis, while the study group patients received the same protocol using 2 patient specific guides (psg) the first guide used for safe and accurate graft harvesting with the proposed dimensions while the second guide used for shell fixation leaving the desired gap with the recipient site that was filled with a particulate mix of xeno and auto grafts .the
first guide was fixed in place allowing for accurate harvesting of the cortical shell of desired dimensions from the symphysis Then; the harvested shell was fixed to the second guide outside the patients mouth using micro screws And this fixation guide was finally secured to its final position using two interlocking wings to lock into the first guide at the surgical site as a verification step for the accuracy of the whole procedure.
Finally, the 2 guides were removed after shell fixation to the recipient site in a through and through manner st the proposed planed position.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Ibrahim Sakr, Bachelor
- Phone Number: 01097891973
- Email: mohamedsakr@dentstry.cu.edu.eg
Study Locations
-
-
-
Giza, Egypt, 12613
- Recruiting
- Faculty of dentistry cairo university
-
Contact:
- Mohamed Mounir Shaker, PHD
- Phone Number: 01001505798
- Email: mohamed.mounir@dentistry.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Age ranges from 25-55 years. No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior mandible with horizontally deficient alveolar ridge that is less than 3mm width.
- Normal vertical dimension with normal inter-arch space.
- The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
Exclusion Criteria:
• Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: horizontal ridge augmentation by computer guided autogenous cortical shell technique
|
computer guided autogenous cortical shell technique
|
ACTIVE_COMPARATOR: horizontal ridge augmentation by free hand autogenous cortical shell technique
|
computer guided autogenous cortical shell technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alveolar ridge horizontal bone gain
Time Frame: one day
|
amount of horizontal bone gain in millimeters measured by cbct
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alveolar ridge horizontal augmentation accuracy in 3D space
Time Frame: one day
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
September 1, 2023
Study Registration Dates
First Submitted
September 23, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (ACTUAL)
September 27, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 27, 2022
Last Update Submitted That Met QC Criteria
September 23, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 13522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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