- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195761
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
January 15, 2026 updated by: Mina ElHadidi Sobhi Ramzi Michael, Cairo University
Radiographic Assessment of Computer Guided Modified Ridge Splitting Technique Versus Conventional Free Hand Technique in Management of Horizontal Deficiency in Posterior Mandible: a Randomized Control Clinical Trial
To assess the accuracy of the computer assessed guides in horizontal bone augmentation achieved at posterior mandible using guided modified ridge splitting technique versus free hand modified ridge splitting technique
Study Overview
Status
Not yet recruiting
Detailed Description
The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.
The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.
Study Type
Interventional
Enrollment (Estimated)
18
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: Mina ElHadidi Sobhi Ramzi, BDS
- Phone Number: +201225339712
- Email: mina.ramzi@dentistry.cu.edu.eg
Study Locations
-
-
Manial
-
Cairo, Manial, Egypt, 12613
- Faculty of Dentistry - Cairo University
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- posterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually
- Age range 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.
- Patients of adequate alveolar bone width.
- Both genders males and females will be included
- Normal vertical dimension with normal inter-arch space. The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent anterior 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.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
- Immunosuppressed or immunocompromised
- Heavy smokers
- Patients undergo medication interfere with bone healing
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: computer guided modified ridge splitting technique (study group)
The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.
|
treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide
Other Names:
|
|
Experimental: conventional modified ridge splitting technique (control group)
The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide
|
treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the Computer Assessed Guide in the study group
Time Frame: immediately postoperative
|
Accuracy of the Computer Assessed Guide in the study group In comparison with the control group between predicted and immediately postoperative horizontal bone width with Cone beam computed tomography in Millimeters measurement tool is CBCT scan superimposition in mm
|
immediately postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar ridge horizontal bone gain
Time Frame: 4 months
|
measure the amount of horizontal bone width gaining by postoperative cone beam computed tomography in millimeters measurement tool is CBCT scan superimposition in mm
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
soft tissue dehiscience
Time Frame: 2 months postoperatively
|
measument tool is periodontal probe to measure the amount of dehscience of the soft tissue
|
2 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohamed Mounir Shaker, BDS,MSc,PHD, Cairo University
- Study Director: Rofaida Atef Abaas, BDS,MSc,PHD, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Al-Ani O, Nambiar P, Ha KO, Ngeow WC. Safe zone for bone harvesting from the interforaminal region of the mandible. Clin Oral Implants Res. 2013 Aug;24 Suppl A100:115-21. doi: 10.1111/j.1600-0501.2011.02393.x. Epub 2012 Jan 11.
- Sanchez-Labrador L, Molinero-Mourelle P, Perez-Gonzalez F, Saez-Alcaide LM, Brinkmann JC, Martinez JL, Martinez-Gonzalez JM. Clinical performance of alveolar ridge augmentation with xenogeneic bone block grafts versus autogenous bone block grafts. A systematic review. J Stomatol Oral Maxillofac Surg. 2021 Jun;122(3):293-302. doi: 10.1016/j.jormas.2020.10.009. Epub 2020 Nov 5.
- De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.
- Schwartz-Arad D, Levin L, Sigal L. Surgical success of intraoral autogenous block onlay bone grafting for alveolar ridge augmentation. Implant Dent. 2005 Jun;14(2):131-8. doi: 10.1097/01.id.0000165031.33190.0d.
- Assaf A, Saad M, Daas M, Abdallah J, Abdallah R. Use of narrow-diameter implants in the posterior jaw: a systematic review. Implant Dent. 2015 Jun;24(3):294-306. doi: 10.1097/ID.0000000000000238.
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 (Estimated)
May 15, 2026
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
June 15, 2026
Study Registration Dates
First Submitted
December 23, 2023
First Submitted That Met QC Criteria
December 23, 2023
First Posted (Actual)
January 8, 2024
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- computer guided modified ridge
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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