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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05602909
Enrollment
7
Registered
2022-11-02
Start date
2022-06-23
Completion date
2023-06-30
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible; Deformity

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.

Interventions

DEVICEGuided 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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in bone densityBaseline,1 month, 3 monthsBone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT
Change in Pain scorreat 1, 7 and 14 daysIt 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)
change in wound healingat 1, 7 and 14 daysThe sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)
Change in mental nerve reflexBaseline, after 2 weeks and 1 monthMental 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

Countries

Egypt

Contacts

Primary ContactAmany M Alrayess, Msc
amany.elrayes@alexu.edu.eg01065080451

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026