CClinicalTrials.gg
Status unknownNCT05556330Updated Sep 27, 2022

Computer Guided Versus Free Hand Horizontal Ridge Augmentation in Anterior Mandible.

An interventional study of computer guided autogenous cortical shell technique in Computer Guided Alveolar Bone Augmentaion, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study summary

Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique:

randomized clinical trial

Read the detailed description

patients with deficient anterior mandible were included in this study where control group patients received free hand harvesting and fixation of cortical shells from the symphysis, while the study group patients received the same protocol using 2 patient specific guides (psg) the first guide used for safe and accurate graft harvesting with the proposed dimensions while the second guide used for shell fixation leaving the desired gap with the recipient site that was filled with a particulate mix of xeno and auto grafts .the first guide was fixed in place allowing for accurate harvesting of the cortical shell of desired dimensions from the symphysis Then; the harvested shell was fixed to the second guide outside the patients mouth using micro screws And this fixation guide was finally secured to its final position using two interlocking wings to lock into the first guide at the surgical site as a verification step for the accuracy of the whole procedure. Finally, the 2 guides were removed after shell fixation to the recipient site in a through and through manner st the proposed planed position.

02

Conditions studied

  • Computer Guided Alveolar Bone Augmentaion
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Age ranges from 25-55 years. No sex predilection.

      • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
      • Edentulous anterior mandible with horizontally deficient alveolar ridge that is less than 3mm width.
      • Normal vertical dimension with normal inter-arch space.
      • The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.

Exclusion criteria

Exclusion Criteria:

    • Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.

      • Previous grafting procedures in the edentulous area.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    horizontal ridge augmentation by computer guided autogenous cortical shell technique

    Procedure: computer guided autogenous cortical shell technique

  • Active comparator
    horizontal ridge augmentation by free hand autogenous cortical shell technique

    Procedure: computer guided autogenous cortical shell technique

Interventions

  • Procedurecomputer guided autogenous cortical shell technique

    computer guided autogenous cortical shell technique

06

What researchers measure

Primary outcomes

  1. Alveolar ridge horizontal bone gain

    amount of horizontal bone gain in millimeters measured by cbct

    Time frame: one day

Secondary outcomes

  1. Alveolar ridge horizontal augmentation accuracy in 3D space

    Time frame: one day

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

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 Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05556330
Lead sponsor
Cairo University
Responsible party
Mohamed Ibrahim Ahmed Sakr (OMFS Resident, Cairo University) — Principal investigator
First posted
Sep 27, 2022
Start date
Jun 1, 2022
Primary completion
Jun 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Sep 27, 2022

Study contacts

Mohamed Ibrahim Sakr, Bachelor
Contact
mohamedsakr@dentstry.cu.edu.eg
01097891973

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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