Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

Not Applicable

Recruiting

• Conditions: Mandible; Deformity
• Interventions: Device: Guided biaxial alveolar distraction device

• Registration Number: NCT05602909
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-10-14
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guided biaxial distraction	Guided biaxial alveolar distraction device	-

Primary Outcome Measures

Name	Time	Method
change in wound healing	at 1, 7 and 14 days	The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)
Change in mental nerve reflex	Baseline, after 2 weeks and 1 month	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
Change in bone density	Baseline,1 month, 3 months	Bone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT
Change in Pain scorre	at 1, 7 and 14 days	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)

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt