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

Sponsor

Future University in Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT05666414

Collaborator

(none)

Enrollment

Location

Arms

12.6

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Procedure: sandwich interpositional bone grafting computer guided Procedure: conventional interpositional bone grafting	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 25, 2021

Actual Primary Completion Date :

Dec 1, 2022

Actual Study Completion Date :

Dec 12, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

amount of vertical bone gain [4 months]
measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy

Secondary Outcome Measures

neurosensory affection [4 months]
measure the affection of the inferior alveolar nerve bundle after performing the interpositional sandwich osteotomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Future University in Egypt	Cairo	New Cairo	Egypt	11865

Sponsors and Collaborators

Future University in Egypt

Investigators

Principal Investigator: ahmed k mohamed, BDS, university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Khaled Mohamed, teaching assisstant, Future University in Egypt

ClinicalTrials.gov Identifier:

NCT05666414

Other Study ID Numbers:

(24)/11-2021

First Posted:

Dec 27, 2022

Last Update Posted:

Jan 3, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 3, 2023