Mandible; DeformityNCT05602909
Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
A study testing Guided biaxial alveolar distraction device in people with Mandible; Deformity, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Mandible; Deformity
- What is being tested?
- Guided biaxial alveolar distraction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
Faculty of Dentistry, (203) 4868308
Amany M Alrayess, Msc
About this study
Official title: 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.
- Conditions
- Mandible; Deformity
- Being tested
- Guided biaxial alveolar distraction device
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided biaxial alveolar distraction deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided biaxial distraction | Experimental | Not described Receives: Device: Guided biaxial alveolar distraction device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline,1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start23 Jun 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandible; DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602909
- Sponsor's protocol ID
- Distractors_2022
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alryess AM, Melek LN, El-Mahallawy Y. Roadmap of computer-guided bi-axial alveolar distraction osteogenesis in the posterior mandible: neurosensory safety of double scan virtual protocol. BMC Oral Health. 2026 May 13;26(1):882. doi: 10.1186/s12903-026-08516-y.
PubMed 42129738
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)
- ClinicalTrials.gov ID
- NCT05602909
- Acronym / sponsor ID
- Distractors_2022
- Conditions
- Mandible; Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided biaxial distraction | Experimental | Device: Guided biaxial alveolar distraction device |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided biaxial alveolar distraction deviceA 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. | Device | Guided biaxial distraction |
Primary outcome
Change in Pain scorre
Time frame: 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)
change in wound healing
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 42129738Alryess AM, Melek LN, El-Mahallawy Y. Roadmap of computer-guided bi-axial alveolar distraction osteogenesis in the posterior mandible: neurosensory safety of double scan virtual protocol. BMC Oral Health. 2026 May 13;26(1):882. doi: 10.1186/s12903-026-08516-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided biaxial alveolar distraction device in people with Mandible; Deformity, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amany M Alrayess, Msc (01065080451 ext. 002, amany.elrayes@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain scorre (time frame: at 1, 7 and 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.