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

NCT05311332 | Completed

• 1 other identifier: FUE.REC (23)\11-2021
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Alveolar Bone Resorption; Horizontal Ridge Deficiency

Keywords

alveolar ridge deficiency; computer guided surgery; chin graft

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge horizontal net bone gain

  volumetric change of deficient alveolar ridge after augmentation

  4 months

Secondary Outcomes (2)

• surgical procedure accuracy

  immediate post operative

• intraoperation time

  at time of surgery

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

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

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

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

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

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

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

future university in Egypt, faculty of dentistry

Cairo, Egypt

Location

Related Publications (1)

• Ayman D, Shawky M, Aly LAA, Mounir M, Zekry AKA. Bone gain and accuracy assessment of computer-guided workflow for horizontal augmentation of atrophic anterior maxilla with symphyseal cortical plates: a randomized controlled trial. BMC Oral Health. 2025 Jul 2;25(1):1039. doi: 10.1186/s12903-025-06415-2.

  PMID: 40604890 DERIVED

Study Officials

• Dina Ayman Fayek, BDS

  teaching assistant oral and maxillofacial department future university in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 5, 2022
• Study Start: October 13, 2021
• Primary Completion: August 20, 2022
• Study Completion: November 1, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

EG (1)