search
Back to results

Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation

Primary Purpose

Alveolar Bone Resorption, Horizontal Ridge Deficiency

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring alveolar ridge deficiency, computer guided surgery, chin graft

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patient free from any systemic condition.
  • Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less than 4 mm measured from outer buccal cortices to outer palatal cortices.
  • Highly motivated patients are willing for the surgical procedure and follow-up, with informed consent.

Exclusion Criteria:

  • Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the osteotomy healing.
  • Medically compromised patients.
  • Uncooperative patients.
  • Patients with any diseases or taking any medications that compromise bone healing

Sites / Locations

  • future university in Egypt, faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique.

Anterior maxilla bone augmentation using free hand autogenous cortical shell technique.

Arm Description

a patient-specific guide was used to harvest a chin cortical shell which was also prepared and positioned at the (anterior horizontally atrophied maxilla) recipient site using another patient-specific positioning guide.

the horizontally atrophic anterior maxilla was augmented with a cortical shell technique the bone was harvested from the chin without a patient-specific guide.

Outcomes

Primary Outcome Measures

Alveolar ridge horizontal net bone gain
volumetric change of deficient alveolar ridge after augmentation

Secondary Outcome Measures

surgical procedure accuracy
depening on the superimposition between immediate postoperative CBCT scan over planning
intraoperation time
duration of surgery

Full Information

First Posted
March 27, 2022
Last Updated
February 14, 2023
Sponsor
Future University in Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT05311332
Brief Title
Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation
Official Title
Assessment of Horizontal Bone Gain Using Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Maxillary Alveolar Ridge Augmentation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
this study aims to evaluate horizontal bone augmentation achieved at the anterior maxilla using computer-guided cortical shell bone technique and accuracy of fixation of the bone shell away from the atrophic ridge by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shell at the ideal position in the conventional protocol it was never guided to be precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting procedures in reducing the risk of anatomical structure damage and patient morbidity with more accuracy compared with the standard technique. this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin).
Detailed Description
Tooth extraction may be due to a variety of causes such as badly decayed, periodontal disease, and trauma whatever the reason tooth loss is always followed by loss of masticatory force and muscle stimulation to the alveolar bone so according to Wolff's Law (Wolff, 1892) loss of mechanical stimulation is followed by the reduction of bone mass. Several surgical protocols have been used to manage horizontal maxillary alveolar bone atrophy such as bone splitting and bone spreading techniques with or without filling the created space, onlay bone graft, guided bone regeneration using resorbable or non-resorbable membrane, distraction osteogenesis, and shell bone block technique which use a thin cortical bone shell to reshape the atrophied ridge and protect the particulate bone graft. Despite the popularity of this technique, it usually requires high surgical skills, prolonged intra-operative time, and unfortunately has some technical drawbacks. Such as lack of anatomical guidance during bone harvesting which may lead to injury to the important vital structure and lack of guidance during fixation may lead to improperly positioned, tilted, or rotated shell or even leaving an undesired distance between the shell and deficient ridge With the increasing use of cone-beam computed tomography (CBCT), intra and extra oral scanner for patient data acquisition, and complete digital workflow in clinical practice and it is rapidly becoming the standard of care in dentistry. Regarding bone augmentation as preparation for future implant placement. computer-aided surgery has been an innovation that enables clinicians to have firm and accurate treatment planning. Also, milling or 3D printing methods allow variable techniques for the fabrication of surgical templates. This study aims to fully digitalize such technique using patient-specific surgical guides to allow for accurate graft harvesting and positioning and to minimize intraoperative time and complications associated with this procedure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption, Horizontal Ridge Deficiency
Keywords
alveolar ridge deficiency, computer guided surgery, chin graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique.
Arm Type
Experimental
Arm Description
a patient-specific guide was used to harvest a chin cortical shell which was also prepared and positioned at the (anterior horizontally atrophied maxilla) recipient site using another patient-specific positioning guide.
Arm Title
Anterior maxilla bone augmentation using free hand autogenous cortical shell technique.
Arm Type
Active Comparator
Arm Description
the horizontally atrophic anterior maxilla was augmented with a cortical shell technique the bone was harvested from the chin without a patient-specific guide.
Intervention Type
Procedure
Intervention Name(s)
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin
Intervention Description
Augmentation of horizontal deficient anterior maxilla using the conventional protocol of cortical shell technique
Intervention Type
Procedure
Intervention Name(s)
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide
Intervention Description
using a patient-specific surgical guide to harvest bone cortical shell from the chin and another patient-specific surgical guide to fix it in the atrophied maxillary anterior area
Primary Outcome Measure Information:
Title
Alveolar ridge horizontal net bone gain
Description
volumetric change of deficient alveolar ridge after augmentation
Time Frame
4 months
Secondary Outcome Measure Information:
Title
surgical procedure accuracy
Description
depening on the superimposition between immediate postoperative CBCT scan over planning
Time Frame
immediate post operative
Title
intraoperation time
Description
duration of surgery
Time Frame
at time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient free from any systemic condition. Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less than 4 mm measured from outer buccal cortices to outer palatal cortices. Highly motivated patients are willing for the surgical procedure and follow-up, with informed consent. Exclusion Criteria: Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the osteotomy healing. Medically compromised patients. Uncooperative patients. Patients with any diseases or taking any medications that compromise bone healing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Ayman Fayek, BDS
Organizational Affiliation
teaching assistant oral and maxillofacial department future university in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
future university in Egypt, faculty of dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the data will be available from the corresponding author upon resonable request.

Learn more about this trial

Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation

We'll reach out to this number within 24 hrs