Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

NCT ID: NCT05602909

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-06-30

Brief Summary

Atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. There are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. Refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.

Conditions

Mandible; Deformity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guided biaxial distraction

Group Type: EXPERIMENTAL

Guided biaxial alveolar distraction device

Intervention Type: DEVICE

A crestal incision will be done, a surgical guide will be placed to assist the correct position of osteotomy, an Extraosseous alveolar distractor will be placed on the ridge to mark screw sites and then will be removed, A distractor will be stabilized to the basal segment with a monocortical screw.

Interventions

Guided biaxial alveolar distraction device

A crestal incision will be done, a surgical guide will be placed to assist the correct position of osteotomy, an Extraosseous alveolar distractor will be placed on the ridge to mark screw sites and then will be removed, A distractor will be stabilized to the basal segment with a monocortical screw.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with the posterior atrophic mandible.
• The distance from the alveolar crest to the upper border of the canal is not less than 5 mm.
• Adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months.
• Patientswithanadequateoralhygiene.
• The patient should be psychologically accepting of the involved procedures.

Exclusion Criteria

• Medically compromised patients contradicting operation (ASA III, IV & V).
• Patients receiving radiotherapy or chemotherapy or bisphosphonate.
• Bonediseases(Osteoporosis,Osteopetrosis,Osteomalacia...etc.)
• Any habits that might retard healing such as heavy smoking and alcoholism.
• A history of any grafting procedure at the designated area.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amany M Alrayess, Msc

Role: CONTACT

amany.elrayes@alexu.edu.eg

01065080451 ext. 002

Facility Contacts

Faculty of Dentistry

Role: primary

(203) 4868308

Other Identifiers

Distractors_2022

Identifier Type: -

Identifier Source: org_study_id