Horizontal Ridge Augmentation of the Mandible Autogenous Block Grafts

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03183336
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans

Condition or Disease	Intervention/Treatment	Phase
Horizontal Ridge Deficiency; Block Graft	Procedure: ridge split interpositional block graft; Procedure: decortication Onlay block graft	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Horizontal Ridge Augmentation of the Mandible Using Interpositional Autogenous Block Grafts Versus Onlay Block Grafts; Randomized Controlled Clinical Trial
• Actual Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2017
• Anticipated Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interpositional block graft ridge split interpositional block graft	Procedure: ridge split interpositional block graft
Active Comparator: Onlay block graft decortication onlay block graft	Procedure: decortication Onlay block graft

Outcome Measures

Primary Outcome Measures

1. alveolar ridge width gained [4 months]

   radiographic analysis following ridge augmentation using Cone beam computed tomography

Secondary Outcome Measures

1. patient morbidity following the surgical procedure [14 days]

   pain value on pain scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.

Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

Exclusion Criteria:

• Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed H Osman, Principle investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03183336
• Other Study ID Numbers: cebc.cairou
• First Posted: Jun 12, 2017
• Last Update Posted: Jul 11, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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 Jul 11, 2017