Dental ImplantNCT07008534
Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement in Atrophic Posterior Mandible
A study testing Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. and IAN lateralization with computer-guided immediate implant placement using Sticky Bone in people with Dental Implant, run by Cairo University.
Trial summary
The aim of this study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. and IAN lateralization with computer-guided immediate implant placement using Sticky Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Apr 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients requiring oral rehabilitation with dental implants in vertically atrophied
- Posterior mandibular region, less than 8mm of bone above the mandibular canal.
- Patients should be free from any systemic conditions that may affect normal healing.
- Absence of any pathological conditions involving mandibular bones.
Who cannot join
- Patients under bisphosphonates treatment.
- Any contraindication for general anaesthesia.
- Osteoporotic patients.
- Patients with neurological disorders (neuralgias, Parkinson' s disease).
- Patients with systematic disease that may complicate healing.
About this study
Official title: Evaluation of Neurosensory Function of Inferior Alveolar Nerve Following Lateralization With Sticky Bone Versus Nil Using Computer Guided Dental Implant Placement: A Randomized Clinical Trial
The aim of this study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main disadvantage of this technique \& provide a reliable,saving time - computer guided simultaneous implant placement- and improved technique.
Read the detailed description
Lateralization of IAN allows simultaneous implant placement with longer implants and primary stability.2 IAN lateralization provides an option to avoid costly, prolonged bone graftt and also healing periods can be reduced by this option of treatment Vestibular depth remains intact as there is no augmentation in the underlying bone defect. 2 IAN lateralization technique has also some advantages such as less morbidity and less of peri-implant disease.2 In case of the IAN is located in the superior part of the body of the mandible , and presence of mild atrophy of the edentulous alveolar ridge will fetch the alveolar ridge in a close relation to the neuro-vascular bundle, The incidence of "high" IAN locations ranges from 14.6 to 30.7%. 1However there is some complications such as numbness after surgery which is considered as the most common one also prevent thermal conductivity via implants(Kahnberg et al., 2000) so sticky bone is going to be used to act as an insulator between dental imlants \& Inferior alveolar nerve and it contains a number of growth factors so it is predicted to play an important role to enhance recovery of the inferior alveolar nerve after surgery
- Conditions
- Dental Implant
- Being tested
- Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only., IAN lateralization with computer-guided immediate implant placement using Sticky Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.Procedure or surgery
Standard procedure without Sticky Bone application.
IAN lateralization with computer-guided immediate implant placement using Sticky BoneProcedure or surgery
The same as the control with additional application of Sticky Bone as an insulator for enhanced neurosensory disfunction
| Study group | Role | What they receive |
|---|---|---|
| Computer guided immediate implant placement & IAN lateralization | Active comparator | Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. Receives: Procedure: Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. |
| computer guided immediate implant placement & IAN lateralization with Sticky bone | Experimental | Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization with sticky bone Receives: Procedure: IAN lateralization with computer-guided immediate implant placement using Sticky Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical neurosensory assessment of inferior alveolar nerve.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ashraf Elsawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008534
- Sponsor's protocol ID
- IAN Lateralization
- Status last verified
- Jul 2025
- First submitted
- 29 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurosensory Function of Inferior Alveolar Nerve Following Lateralization With Sticky Bone Versus Nil Using Computer Guided Dental Implant Placement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07008534
- Acronym / sponsor ID
- IAN Lateralization
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Jun 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 study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main disadvantage of this technique \& provide a reliable,saving time - computer guided simultaneous implant placement- and improved technique.
Detailed description
Lateralization of IAN allows simultaneous implant placement with longer implants and primary stability.2 IAN lateralization provides an option to avoid costly, prolonged bone graftt and also healing periods can be reduced by this option of treatment Vestibular depth remains intact as there is no augmentation in the underlying bone defect. 2 IAN lateralization technique has also some advantages such as less morbidity and less of peri-implant disease.2 In case of the IAN is located in the superior part of the body of the mandible , and presence of mild atrophy of the edentulous alveolar ridge will fetch the alveolar ridge in a close relation to the neuro-vascular bundle, The incidence of "high" IAN locations ranges from 14.6 to 30.7%. 1However there is some complications such as numbness after surgery which is considered as the most common one also prevent thermal conductivity via implants(Kahnberg et al., 2000) so sticky bone is going to be used to act as an insulator between dental imlants \& Inferior alveolar nerve and it contains a number of growth factors so it is predicted to play an important role to enhance recovery of the inferior alveolar nerve after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer guided immediate implant placement & IAN lateralization | Active comparator | Procedure: Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. |
| computer guided immediate implant placement & IAN lateralization with Sticky bone | Experimental | Procedure: IAN lateralization with computer-guided immediate implant placement using Sticky BonePatients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization with sticky bone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients requiring oral rehabilitation with dental implants in vertically atrophied
Key exclusion criteria (5 listed)
- Patients under bisphosphonates treatment.
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 |
|---|---|---|
| Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.Standard procedure without Sticky Bone application. | Procedure or surgery | Computer guided immediate implant placement & IAN lateralization |
| IAN lateralization with computer-guided immediate implant placement using Sticky BoneThe same as the control with additional application of Sticky Bone as an insulator for enhanced neurosensory disfunction | Procedure or surgery | computer guided immediate implant placement & IAN lateralization with Sticky bone |
Primary outcome
Clinical neurosensory assessment of inferior alveolar nerve.
Time frame: 6 months
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 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only. and IAN lateralization with computer-guided immediate implant placement using Sticky Bone in people with Dental Implant, run by Cairo University.
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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 assessment of inferior alveolar nerve. (time frame: 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 9 Jul 2025.