Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

Hams Hamed Abdelrahman7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandible; Deformity

Interventions

Guided biaxial alveolar distraction deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Alexandria, Azarita, Egypt

RECRUITING

Outcomes

Primary Outcomes

Change in Pain scorre

It will be assessed on daily basis for one week through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Time frame: at 1, 7 and 14 days

change in wound healing

The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)

Time frame: at 1, 7 and 14 days

Change in mental nerve reflex

Mental nerve blink reflex responses to electrical stimuli given with a small bipolar pediatric stimulating electrode to the center of the mental nerve distribution on the chin and lower lip on each side will be recorded bilaterally with surface electrodes on the orbicularis oculi muscles with Viking IV EMG equipment

Time frame: Baseline, after 2 weeks and 1 month

Change in bone density

Bone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT

Time frame: Baseline,1 month, 3 months

Central Contacts

Amany M Alrayess, Msc

CONTACT

01065080451 amany.elrayes@alexu.edu.eg

Data from ClinicalTrials.gov

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