Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

NCT05602909 | Unknown

• 1 other identifier: Distractors_2022
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Guided biaxial distraction

EXPERIMENTAL

Device: Guided biaxial alveolar distraction device

Interventions

Guided biaxial alveolar distraction device 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.

Guided biaxial distraction

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

RECRUITING

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amany M Alrayess, Msc

CONTACT

01065080451; amany.elrayes@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 2, 2022
• Study Start: June 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

EG (1)