Back to resultsGuided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
Primary Purpose
Mandible; Deformity
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Guided biaxial alveolar distraction device
Sponsored by
About this trial
This is an interventional treatment trial for Mandible; Deformity
Eligibility Criteria
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.
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, EgyptRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guided biaxial distraction
Arm Description
Outcomes
Primary Outcome Measures
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)
change in wound healing
The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05602909
First Posted
October 14, 2022
Last Updated
November 1, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05602909
Brief Title
Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
Official Title
Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible; Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided biaxial distraction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Guided biaxial alveolar distraction device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain scorre
Description
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)
Time Frame
at 1, 7 and 14 days
Title
change in wound healing
Description
The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)
Time Frame
at 1, 7 and 14 days
Title
Change in mental nerve reflex
Description
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
Time Frame
Baseline, after 2 weeks and 1 month
Title
Change in bone density
Description
Bone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT
Time Frame
Baseline,1 month, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amany M Alrayess, Msc
Phone
01065080451
Ext
002
Email
amany.elrayes@alexu.edu.eg
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Dentistry
Phone
(203) 4868308
First Name & Middle Initial & Last Name & Degree
Amany M Alrayess, Msc
12. IPD Sharing Statement
Learn more about this trial
Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
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