Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy

Assessment of Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy Technique in the Atrophied Posterior Mandible: a Randomized Clinical Trial

The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.

Study Overview

• Status: Completed
• Conditions: Bone Loss
• Intervention / Treatment: Procedure: sandwich interpositional bone grafting computer guided; Procedure: conventional interpositional bone grafting

Detailed Description

in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 11865
      • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal

  • Good oral hygiene
  • Highly motivated patients
  • Patients seeking fixed prosthesis at posterior mandibular region.
  • Patients willing for a surgical procedures follow-up with an informed consent
  • Age range 20-65 years

Exclusion Criteria:

• • Smokers

  • Individuals with dentulous posterior mandible ridge
  • Medically compromised patients
  • Patients with local pathosis at the surgical area suggested
  • Previously subjected to reconstructive procedures of the posterior mandible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: computer guided sandwich interpositional bone grafting; patient specific cutting guide were fabricated to perform the osteotomies ( and another patient specific guide was then fabricated to start the fixation of the cut bony segment a full digital intervention for sandwich interpositional grafting in patients with vertically atrophied mandible (bilateral split mouth study)	Procedure: sandwich interpositional bone grafting computer guided; performing the 2 vertical and the 1 horizontal osteotomies using a cutting patient specific guide and fixation of the vertically elevated bony segment after gap calculation using patient specific fixation guides
Active Comparator: conventional sandwich osteotomy interpositional bone grafting; conventional interpositional bone grafting was done for patients with vertically atrophied mandibles (bilateral split mouth study)	Procedure: conventional interpositional bone grafting; performing the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of vertical bone gain	measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurosensory affection	measure the affection of the inferior alveolar nerve bundle after performing the interpositional sandwich osteotomy	4 months

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Principal Investigator: ahmed k mohamed, BDS, University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: (24)/11-2021

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