Posterior Atrophic MandibleNCT04590339
Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation
A study testing Guided inferior Alveolar Nerve lateralization in people with Posterior Atrophic Mandible and Inferior Alveolar Nerve, run by Alexandria University at 1 site in Egypt.
Trial summary
Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. In many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (IAN). Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Atrophic Mandible, Inferior Alveolar Nerve, Nerve Lateralization
- What is being tested?
- Guided inferior Alveolar Nerve lateralization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2018to 10 Jan 2021
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients suffering from unilateral posterior mandibular edentulism and having < 8 mm of bone above the mandibular canal.
- The width of the ridge should be > 4mm.
- The patient should be psychologically accepting the implant and the involved procedures.
- The patients should have adequate oral hygiene and adequate bone quality.
Who cannot join
- Any absolute contraindication for implant surgery such as uncontrolled diabetes mellitus, blood and/or bleeding disorders, serious osseous defects…etc.
- Any relevant systemic disease directly affecting bone metabolism and healing.
- Any habits that might reduce the blood flow and retard healing such as heavy smoking and alcoholism.
- A history of any grafting procedure at the designated area.
- Patient with thick cortical bone buccally and a thin neurovascular bundle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation: A Randomized Controlled Clinical Trial
Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. In many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (IAN). IANL is defined as the lateralization of inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of the incisive nerve; exposure and traction are used to deflect the IAN laterally while the implants are placed.
Read the detailed description
This prospective randomized clinical trial will enroll 20 patients with posterior mandibular ridge atrophy. Ten of which will undergo computer guided nerve lateralization with subsequent implant placement and repositioning of the osteomotized bone window and ten patients will undergo computer guided nerve lateralization with subsequent implant placement and sticky bone grafting.
- Being tested
- Guided inferior Alveolar Nerve lateralization
- Keywords
- inferior Alveolar nerve lateralization, neurosensory disturbance, guided surgery, Posterior atrophic mandibular ridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided inferior Alveolar Nerve lateralizationProcedure or surgery
Also called computer guided implant placement
Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique
| Study group | Role | What they receive |
|---|---|---|
| Repositioning the bone window | Active comparator | Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window. Receives: Procedure: Guided inferior Alveolar Nerve lateralization |
| Augmentation using sticky bone | Active comparator | Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone Receives: Procedure: Guided inferior Alveolar Nerve lateralization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)
Electrophysiological test using Mental nerve Blink reflex is done for each patient before surgery(base line), after surgery at 1 month, 3 months and 6 months.
Measured: 1 month, 3 months and 6 months
Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Measured: 1 week, 1 month, 3 months and 6 months
Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Measured: 1 week, 1 month, 3 months and 6 months
Clinical assessment of the change in neurosensory function recovery using two point discrimination test
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Measured: 1 week, 1 month, 3 months and 6 months
Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Measured: 1 week, 1 month, 3 months and 6 months
Secondary outcomes (1)
Implant Success rate
Implant Stability using osstell device to measure the implant success at the time of implant insertion, after 3 month and at 6 month.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Oct 2018
- Primary completion10 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Atrophic MandibleStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina N. Metawie, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590339
- Sponsor's protocol ID
- 0010556-IORG 00088390
- Status last verified
- Jul 2021
- First submitted
- 12 Aug 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04590339
- Acronym / sponsor ID
- 0010556-IORG 00088390
- Keywords
- inferior Alveolar nerve lateralization, neurosensory disturbance, guided surgery, Posterior atrophic mandibular ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 19 Oct 2020 (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.
Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. In many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (IAN). IANL is defined as the lateralization of inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of the incisive nerve; exposure and traction are used to deflect the IAN laterally while the implants are placed.
Detailed description
This prospective randomized clinical trial will enroll 20 patients with posterior mandibular ridge atrophy. Ten of which will undergo computer guided nerve lateralization with subsequent implant placement and repositioning of the osteomotized bone window and ten patients will undergo computer guided nerve lateralization with subsequent implant placement and sticky bone grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repositioning the bone window | Active comparator | Procedure: Guided inferior Alveolar Nerve lateralizationComputer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window. |
| Augmentation using sticky bone | Active comparator | Procedure: Guided inferior Alveolar Nerve lateralizationComputer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients suffering from unilateral posterior mandibular edentulism and having < 8 mm of bone above the mandibular canal.
- The width of the ridge should be > 4mm.
- The patient should be psychologically accepting the implant and the involved procedures.
- The patients should have adequate oral hygiene and adequate bone quality.
Key exclusion criteria (5 listed)
- Any absolute contraindication for implant surgery such as uncontrolled diabetes mellitus, blood and/or bleeding disorders, serious osseous defects…etc.
- Any relevant systemic disease directly affecting bone metabolism and healing.
- Any habits that might reduce the blood flow and retard healing such as heavy smoking and alcoholism.
- A history of any grafting procedure at the designated area.
- Patient with thick cortical bone buccally and a thin neurovascular bundle.
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 inferior Alveolar Nerve lateralizationAlso: computer guided implant placementEvaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique | Procedure or surgery | Augmentation using sticky bone, Repositioning the bone window |
Primary outcome
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)
Time frame: 1 month, 3 months and 6 months
Electrophysiological test using Mental nerve Blink reflex is done for each patient before surgery(base line), after surgery at 1 month, 3 months and 6 months.
Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.
Time frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.
Time frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using two point discrimination test
Time frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.
Time frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
1 secondary outcome
Implant Success rate
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Dina N. Metawie principal investigator
Alexandria University
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 inferior Alveolar Nerve lateralization in people with Posterior Atrophic Mandible and Inferior Alveolar Nerve, run by Alexandria University 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 4 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: finished, as of the sponsor's last update on 28 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line) (time frame: 1 month, 3 months and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.