Neurosensory Function of Inferior Alveolar NerveIANLNCT06961045
Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement Will be Performed on 10 Surgical Sides (Mandibular Quadrants) to Evaluate the Postoperative Neurosensory Disturbances Following Guided Inferior Alveolar Nerve Lateralization
A study testing Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement in people with Neurosensory Function of Inferior Alveolar Nerve, run by AYMAN M. ARAKEEP, MSc, PhD researcher at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to primarily evaluate the postoperative neurosensory disturbances following guided inferior alveolar nerve lateralization with simultaneous implant placement in 10 surgical sides (mandibular quadrants distal to the mental foramen) either in males or females with age range from 30 to… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Neurosensory Function of Inferior Alveolar Nerve
- What is being tested?
- Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrophic mandibular ridges distal to the mental foramen with residual alveolar bone height ≤ 8 mm above the IAN.
- The width of the alveolar ridge ≥ 6 mm, 3mm down from the alveolar crest.
Who cannot join
- All patients suffering from any systemic disease that may contraindicate implant surgery or affect bone healing and osseointegration of implant.
- Previous history of bone augmentation or implant placement in the site planned for nerve lateralization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Tanta University, Egypt
Tanta, Gharbia Governorate, 31527
About this study
Official title: Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement
The aim of this clinical trial is to primarily evaluate the postoperative neurosensory disturbances following guided inferior alveolar nerve lateralization with simultaneous implant placement in 10 surgical sides (mandibular quadrants distal to the mental foramen) either in males or females with age range from 30 to 75 years. The main questions it aims to answer are:
- Will the postoperative neurosensory disturbances after the surgical intervention fade out and if not, will it be annoying to the patient?
- Can we consider inferior alveolar nerve lateralization efficient substitute to short implants?
- will the inserted implants going to be properly ossteointegrated at the site of osteotomy for lateralization?
- Being tested
- Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement
- Keywords
- Inferior Alveolar Nerve Lateraliztion, Computer Assisted, Clinical neurosensory Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant PlacementProcedure or surgery
All patients will be operated on under general anesthesia. A para-crestal incision will be done and a mucoperiosteal flap will be reflected exposing the alveolar ridge and the buccal cortex. The surgical guide will be fitted and fixed in place and the outline of the window will be drawn by the aid of the surgical guide using the piezotome then the guide will be removed. Once the osteotomy is completed the bone window will be mobilized for exposure of the neurovascular bundle. The diamond tips will be used for removal of any remaining bone around the nerve. The neurovascular bundle will be dissected and retracted properly. a surgical guide will be inserted for implant osteotomy. The bone block which was removed for the buccal window will be crushed to be particulates and will be mixed with autologous fibrin glue for preparation of sticky bone, the sticky bone will be packed gently in the window area around the neurovascular bundle then will be covered by platelet rich fibrin.
| Study group | Role | What they receive |
|---|---|---|
| Main single arm for the clinical trial | Other | Not described Receives: Procedure: Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical neurosensory testing of the inferior alveolar nerve function
We will use the light touch test and sensitivity mapping by applying moderated pressure with a periodontal probe to depress the skin by 1-2 mm while the patients will be seated comfortably in a quiet room with their eyes closed throughout the procedures. We will show the hypo aesthetic area as a graphic to illustrate its extension. We will choose this technique because it selects the dysfunction of rapidly adapting long myelinated fibers, which are 90% of the fibers of the IAN.
Measured: Postoperatively 1 week, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start21 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosensory Function of Inferior Alveolar NerveStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AYMAN M. ARAKEEP, MSc, PhD researcher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYMAN M. ARAKEEP, MSc, PhD researcher, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961045
- Sponsor's protocol ID
- OS 4-24 2184
- Acronym
- IANL
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: every necessary individual participant data required for any publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement
- ClinicalTrials.gov ID
- NCT06961045
- Acronym / sponsor ID
- IANL / OS 4-24 2184
- Keywords
- Inferior Alveolar Nerve Lateraliztion, Computer Assisted, Clinical neurosensory Testing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AYMAN M. ARAKEEP, MSc, PhD researcherUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 May 2025 (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.
The aim of this clinical trial is to primarily evaluate the postoperative neurosensory disturbances following guided inferior alveolar nerve lateralization with simultaneous implant placement in 10 surgical sides (mandibular quadrants distal to the mental foramen) either in males or females with age range from 30 to 75 years. The main questions it aims to answer are:
- Will the postoperative neurosensory disturbances after the surgical intervention fade out and if not, will it be annoying to the patient?
- Can we consider inferior alveolar nerve lateralization efficient substitute to short implants?
- will the inserted implants going to be properly ossteointegrated at the site of osteotomy for lateralization?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main single arm for the clinical trial | Other | Procedure: Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Atrophic mandibular ridges distal to the mental foramen with residual alveolar bone height ≤ 8 mm above the IAN.
- The width of the alveolar ridge ≥ 6 mm, 3mm down from the alveolar crest.
Key exclusion criteria (2 listed)
- All patients suffering from any systemic disease that may contraindicate implant surgery or affect bone healing and osseointegration of implant.
- Previous history of bone augmentation or implant placement in the site planned for nerve lateralization.
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 Lateralization with Simultaneous Implant PlacementAll patients will be operated on under general anesthesia. A para-crestal incision will be done and a mucoperiosteal flap will be reflected exposing the alveolar ridge and the buccal cortex. The surgical guide will be fitted and fixed in place and the outline of the window will be drawn by the aid of the surgical guide using the piezotome then the guide will be removed. Once the osteotomy is completed the bone window will be mobilized for exposure of the neurovascular bundle. The diamond tips will be used for removal of any remaining bone around the nerve. The neurovascular bundle will be dissected and retracted properly. a surgical guide will be inserted for implant osteotomy. The bone block which was removed for the buccal window will be crushed to be particulates and will be mixed with autologous fibrin glue for preparation of sticky bone, the sticky bone will be packed gently in the window area around the neurovascular bundle then will be covered by platelet rich fibrin. | Procedure or surgery | Main single arm for the clinical trial |
Primary outcome
clinical neurosensory testing of the inferior alveolar nerve function
Time frame: Postoperatively 1 week, 1 month, 3 months, 6 months
We will use the light touch test and sensitivity mapping by applying moderated pressure with a periodontal probe to depress the skin by 1-2 mm while the patients will be seated comfortably in a quiet room with their eyes closed throughout the procedures. We will show the hypo aesthetic area as a graphic to illustrate its extension. We will choose this technique because it selects the dysfunction of rapidly adapting long myelinated fibers, which are 90% of the fibers of the IAN.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes. every necessary individual participant data required for any publication will be shared
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.
The record lists no contact. Use the official record to reach the sponsor.
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 with Simultaneous Implant Placement in people with Neurosensory Function of Inferior Alveolar Nerve, run by AYMAN M. ARAKEEP, MSc, PhD researcher 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 7 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
clinical neurosensory testing of the inferior alveolar nerve function (time frame: Postoperatively 1 week, 1 month, 3 months, 6 months). 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 7 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.