Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

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

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 Overview

• Status: Recruiting
• Conditions: Mandible; Deformity
• Intervention / Treatment: Device: Guided biaxial alveolar distraction device

• Study Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amany M Alrayess, Msc; Phone Number: 002 01065080451; Email: amany.elrayes@alexu.edu.eg

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Recruiting
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
      • Contact: Faculty of Dentistry; Phone Number: (203) 4868308
      • Principal Investigator: Amany M Alrayess, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided biaxial distraction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Distractors_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No