Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

Mandible; Deformity Clinical Trial

Official title:

Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602909
• Other study ID #: Distractors_2022
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: Amany M Alrayess, Msc
• Phone: 01065080451
• Email: amany.elrayes[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Mandible; Deformity

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at 1, 7 and 14 days
Primary	change in wound healing	The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)	at 1, 7 and 14 days
Primary	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	Baseline, after 2 weeks and 1 month
Primary	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	Baseline,1 month, 3 months