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NCT05666414 Clinical Trial

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

Bone Loss Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05666414
Other study ID # (24)/11-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2021
Est. completion date December 12, 2022

Study information
Verified date December 2022
Source Future University in Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date December 12, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Future University in Egypt Cairo New Cairo

Sponsors (1)
Lead Sponsor Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary amount of vertical bone gain measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy 4 months
Secondary neurosensory affection measure the affection of the inferior alveolar nerve bundle after performing the interpositional sandwich osteotomy 4 months
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