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

NCT05666414 | Completed

• 1 other identifier: (24)/11-2021
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (1)

• amount of vertical bone gain

  measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy

  4 months

Secondary Outcomes (1)

• neurosensory affection

  4 months

Study Arms (2)

computer guided sandwich interpositional bone grafting

EXPERIMENTAL

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

conventional sandwich osteotomy interpositional bone grafting

ACTIVE COMPARATOR

conventional interpositional bone grafting was done for patients with vertically atrophied mandibles (bilateral split mouth study)

Procedure: conventional interpositional bone grafting

Interventions

sandwich interpositional bone grafting computer guided PROCEDURE

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

computer guided sandwich interpositional bone grafting

conventional interpositional bone grafting PROCEDURE

performing the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand

conventional sandwich osteotomy interpositional bone grafting

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• ahmed k mohamed, BDS

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assisstant

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: November 25, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 12, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)