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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05556330
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

randomized clinical trial

Condition or Disease	Intervention/Treatment	Phase
Computer Guided Alveolar Bone Augmentaion	Procedure: computer guided autogenous cortical shell technique	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Alveolar ridge horizontal bone gain [one day]

   amount of horizontal bone gain in millimeters measured by cbct

Secondary Outcome Measures

1. Alveolar ridge horizontal augmentation accuracy in 3D space [one day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: 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:

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

• Previous grafting procedures in the edentulous area.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry Cairo University	Giza		Egypt	12613

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Ibrahim Ahmed Sakr, OMFS Resident, Cairo University
• ClinicalTrials.gov Identifier: NCT05556330
• Other Study ID Numbers: 13522
• First Posted: Sep 27, 2022
• Last Update Posted: Sep 27, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 27, 2022