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CompletedNCT05311332Updated Feb 15, 2023

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

An interventional study of Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin and Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide in Alveolar Bone Resorption and Horizontal Ridge Deficiency, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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).

Read the 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

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Conditions studied

  • Alveolar Bone Resorption
  • Horizontal Ridge Deficiency

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Keywords

  • alveolar ridge deficiency
  • computer guided surgery
  • chin graft
03

In context

Bone Resorption

153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.

This study's enrollment of 14 is below the median of 22 across 133 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

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

    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.

    Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide

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

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

    Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin

Interventions

  • ProcedureAugmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin

    Augmentation of horizontal deficient anterior maxilla using the conventional protocol of cortical shell technique

  • ProcedureAugmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide

    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

06

What researchers measure

Primary outcomes

  1. Alveolar ridge horizontal net bone gain

    volumetric change of deficient alveolar ridge after augmentation

    Time frame: 4 months

Secondary outcomes

  1. surgical procedure accuracy

    depening on the superimposition between immediate postoperative CBCT scan over planning

    Time frame: immediate post operative

  2. intraoperation time

    duration of surgery

    Time frame: at time of surgery

07

Study locations

1 site
  • future university in Egypt, faculty of dentistry
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: Undecided — the data will be available from the corresponding author upon resonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05311332
Lead sponsor
Future University in Egypt
Responsible party
Dina Ayman (assistant lecturer, Future University in Egypt) — Principal investigator
First posted
Apr 5, 2022
Start date
Oct 13, 2021
Primary completion
Aug 20, 2022
Completion
Nov 1, 2022
Last update
Feb 15, 2023

Study contacts

Dina Ayman Fayek, BDS
principal investigator · teaching assistant oral and maxillofacial department future university in Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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