Accuracy Assessment of Chin Graft for Ridge Augmentation Using Tooth-supported Guide Versus Free Hand Technique

NCT07365852 | Completed DMC

• 1 other identifier: 4596
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the accuracy of osteotomies positions using patient specific guides for onlay bone shells harvested from the chin then the graft positioning for 3D upper anterior ridge augmentation using patient-specific tooth-supported guide versus free hand technique

Conditions

Alveolar Bone Loss

Keywords

ridge augmentation; onlay grafting; tooth-supported guide; patient-specific guide; maxillary bone augmentation; chin graft

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge width bone gain

  measures will be obtained from CT scan in millimetres

  4 months

Secondary Outcomes (1)

• Alveolar ridge vertical bone gain

  4 months

Other Outcomes (1)

• Accuracy of the Computer-assisted guide in the study group

  immediate post-operative

Study Arms (2)

Tooth-supported Patient-specific Surgical Guide

EXPERIMENTAL

In this study computer-designed patient-specific surgical osteotomy guide provides accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell.

Procedure: 3D ridge augmentation using tooth-supported patient-specific guide

Free hand technique

ACTIVE COMPARATOR

The cortical bone harvested from chin area without surgical guide, then the non-guided mono-cortical bone block grafting will be fixed on the ridge labially using 2 micro screws and one through and through for the palatal shell.

Procedure: 3D ridge augmentation using tooth-supported patient-specific guide

Interventions

3D ridge augmentation using tooth-supported patient-specific guide PROCEDURE

In this study computer-designed patient-specific surgical osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell.

Free hand technique; Tooth-supported Patient-specific Surgical Guide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Anterior maxilla with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually, combined with vertical deficiency.
• Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
• Both genders males and females will be included
• Normal vertical dimension with normal inter-arch space

You may not qualify if:

• Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
• General contraindications to implant surgery.
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing females.
• Immunosuppressed or immunocompromised
• Heavy smokers
• Patients undergo medication interfere with bone healing

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 12311, Egypt

Location

Related Publications (5)

• Aloy-Prosper A, Carramolino-Cuellar E, Penarrocha-Oltra D, Soto-Penaloza D, Penarrocha-Diago M. Intraoral onlay block bone grafts versus cortical tenting technique on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e181-e190. doi: 10.4317/medoral.25169.

  PMID: 35218647 BACKGROUND

• Cansiz E, Haq J, Manisali M, Cakarer S, Gultekin BA. Long-term evaluation of three-dimensional volumetric changes of augmented severely atrophic maxilla by anterior iliac crest bone grafting. J Stomatol Oral Maxillofac Surg. 2020 Dec;121(6):665-671. doi: 10.1016/j.jormas.2019.11.004. Epub 2020 Feb 8.

  PMID: 32045687 BACKGROUND

• Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available.

  PMID: 19885450 BACKGROUND

• De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.

  PMID: 27977816 BACKGROUND

• Naishlos S, Zenziper E, Zelikman H, Nissan J, Mizrahi S, Chaushu G, Matalon S, Chaushu L. Esthetic Assessment Succeeding Anterior Atrophic Maxilla Augmentation with Cancellous Bone-Block Allograft and Late Restoration Loading. J Clin Med. 2021 Oct 9;10(20):4635. doi: 10.3390/jcm10204635.

  PMID: 34682757 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Wesam Sami, Bachelor

  Cairo University

  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: Resident at oral and maxillofacial surgery department

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: January 26, 2026
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)