Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
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
Sponsor
Sponsor
Investigators
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
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
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- computer guided modified ridge
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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