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

Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial

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

randomized clinical trial

Study Overview

• Status: Recruiting
• Conditions: Computer Guided Alveolar Bone Augmentaion
• Intervention / Treatment: Procedure: computer guided autogenous cortical shell technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ibrahim Sakr, Bachelor; Phone Number: 01097891973; Email: mohamedsakr@dentstry.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Recruiting
    • Faculty of Dentistry Cairo University
    • Contact: Mohamed Mounir shaker, PhD; Phone Number: 01001505798; Email: Mohamed.mounir@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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

  • Previous grafting procedures in the edentulous area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: horizontal ridge augmentation by computer guided autogenous cortical shell technique	Procedure: computer guided autogenous cortical shell technique; 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; computer guided autogenous cortical shell technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge horizontal bone gain	amount of horizontal bone gain in millimeters measured by cbct	one day

Secondary Outcome Measures

Outcome Measure	Time Frame
Alveolar ridge horizontal augmentation accuracy in 3D space	one day

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (ACTUAL): September 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 13522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No