Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla

In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. So using the computer guided in segmental sandwich osteotomy and fixation the transport segment hopefully will reduce the bucco-palatal tipping.

Study Overview

• Status: Unknown
• Conditions: Sandwich Osteotomy
• Intervention / Treatment: Procedure: computer guided sandwich osteotomy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with vertically deficient anterior maxillary ridge a minimum 10 mm. height of alveolar bone.
• Patients with medical history that did not hinder implant placement (uncontrolled diabetes) and adequate proper oral hygiene.
• Patients of adequate alveolar bone width.
• Both genders males and females will be included.

Exclusion Criteria:

• 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.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
• Active infection or severe inflammation in the area intended for implant placement.
• Need of bone augmentation procedures at implant placement.
• Unable to open mouth sufficiently to accommodate the surgical tooling.
• Patients participating in other studies, if the present protocol could not be properly followed.
• Referred only for implant placement or unable to attend a 5-year follow-up.
• Requiring only single implant-supported crowns.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: computer guided sandwich osteotomy; segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group.	Procedure: computer guided sandwich osteotomy; segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group.
ACTIVE_COMPARATOR: conventional sandwich osteotomy; :conventional segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla.	Procedure: computer guided sandwich osteotomy; segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bucco - palatal tipping	calculate the amount of bucco-palaltal tipping of mobilized transport segment after 6 months in mm by cone beam CT between both groups.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone loss	calculate marginal bone loss in mm by cone beam CT between two groups	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: shareif nazzal, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-18-06-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No