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

NCT ID: NCT05556330

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-09-30

Brief Summary

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

randomized clinical trial

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.

Conditions

Computer Guided Alveolar Bone Augmentaion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

horizontal ridge augmentation by computer guided autogenous cortical shell technique

Group Type: EXPERIMENTAL

computer guided autogenous cortical shell technique

Intervention Type: PROCEDURE

computer guided autogenous cortical shell technique

horizontal ridge augmentation by free hand autogenous cortical shell technique

Group Type: ACTIVE_COMPARATOR

computer guided autogenous cortical shell technique

Intervention Type: PROCEDURE

computer guided autogenous cortical shell technique

Interventions

computer guided autogenous cortical shell technique

computer guided autogenous cortical shell technique

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ibrahim Ahmed Sakr

OMFS Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Ibrahim Sakr, Bachelor

Role: CONTACT

mohamedsakr@dentstry.cu.edu.eg

01097891973

Facility Contacts

Mohamed Mounir Shaker, PHD

Role: primary

mohamed.mounir@dentistry.cu.edu.eg

01001505798

Other Identifiers

13522

Identifier Type: -

Identifier Source: org_study_id