Inferior Alveolar ApproximationNCT07363239
CBCT-Based Safety Distance for Implant Placement Near the Inferior Alveolar Canal
An observational study of Inferior Alveolar Approximation and Implants, run by Cairo University.
Trial summary
o evaluate the radiologic proximity of mandibular dental implants placed less than 2 mm from the inferior alveolar canal using cone-beam computed tomography (CBCT), and to determine the relationship between implant-canal distance and the occurrence of postoperative neurosensory disturbances. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Approximation, Implants
- What is being tested?
- nerve approximation group
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2027to 30 Jan 2027
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of adult patients with available CBCT scans, retrospectively evaluated for implant-related anatomical assessment in the region of the inferior alveolar canal.
Who may be able to join
- Age ≥ 21 years.
- Implants placed in mandibular first/second premolar or molar positions (Froum et al., 2021).
- Patients without neurosensory changes following implant placement and healing (Froum et al., 2021).
- Patients with neurosensory changes after implant placement, including paresthesia, anesthesia, dysesthesia (and neuralgia where applicable) (Froum et al., 2021).
Who cannot join
- Incomplete records preventing outcome ascertainment (Froum et al., 2021).
- Refusal/unavailability of postoperative CBCT when clinically required for evaluation (Froum et al., 2021).
- Poor-quality CBCT scans or scatter artifacts interfering with evaluation (Froum et al., 2021).
- Contraindications for radiographs (e.g., pregnancy/breastfeeding) in cases where additional imaging would otherwise be clinically required (Froum et al., 2021).
- Implants placed after mental foramen
About this study
Official title: A New Concept of Safety Distance to Place Implants in the Area of the Inferior Alveolar Canal to Avoid Neurosensory Disturbance: A Retrospective CBCT Study
- evaluate the radiologic proximity of mandibular dental implants placed less than 2 mm from the inferior alveolar canal using cone-beam computed tomography (CBCT), and to determine the relationship between implant-canal distance and the occurrence of postoperative neurosensory disturbances.
- Conditions
- Inferior Alveolar Approximation, Implants
- Being tested
- nerve approximation group
- Keywords
- inferior alveolar nerve, implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve approximation groupOther
implants placed with distance more than 2 mm from the inferior alveolar canal
| Study group | Role | What they receive |
|---|---|---|
| implants placed more than 2mm from the inferior alveolar canal | Not described Receives: Other: nerve approximation group | |
| Implant proximity < 2 mm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurosensory outcome
presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)
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 posted23 Jan 2026
- Study start20 Jan 2027 (estimated)
- Primary completion25 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Alveolar ApproximationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Adayil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363239
- Sponsor's protocol ID
- 12/25
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Concept of Safety Distance to Place Implants in the Area of the Inferior Alveolar Canal to Avoid Neurosensory Disturbance: A Retrospective CBCT Study
- ClinicalTrials.gov ID
- NCT07363239
- Acronym / sponsor ID
- 12/25
- Conditions
- Inferior Alveolar Approximation, Implants
- Keywords
- inferior alveolar nerve, implants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2027 (estimated)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
- evaluate the radiologic proximity of mandibular dental implants placed less than 2 mm from the inferior alveolar canal using cone-beam computed tomography (CBCT), and to determine the relationship between implant-canal distance and the occurrence of postoperative neurosensory disturbances.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implants placed more than 2mm from the inferior alveolar canal | – | Other: nerve approximation group |
| Implant proximity < 2 mm | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with available CBCT scans, retrospectively evaluated for implant-related anatomical assessment in the region of the inferior alveolar canal.
Key inclusion criteria (4 listed)
- Age ≥ 21 years.
- Implants placed in mandibular first/second premolar or molar positions (Froum et al., 2021).
- Patients without neurosensory changes following implant placement and healing (Froum et al., 2021).
- Patients with neurosensory changes after implant placement, including paresthesia, anesthesia, dysesthesia (and neuralgia where applicable) (Froum et al., 2021).
Key exclusion criteria (5 listed)
- Incomplete records preventing outcome ascertainment (Froum et al., 2021).
- Refusal/unavailability of postoperative CBCT when clinically required for evaluation (Froum et al., 2021).
- Poor-quality CBCT scans or scatter artifacts interfering with evaluation (Froum et al., 2021).
- Contraindications for radiographs (e.g., pregnancy/breastfeeding) in cases where additional imaging would otherwise be clinically required (Froum et al., 2021).
- Implants placed after mental foramen
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 |
|---|---|---|
| nerve approximation groupimplants placed with distance more than 2 mm from the inferior alveolar canal | Other | implants placed more than 2mm from the inferior alveolar canal |
Primary outcome
Neurosensory outcome
Time frame: 6 months
presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)
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 19 Mar 2026.
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?
An observational study of Inferior Alveolar Approximation and Implants, 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 19 Mar 2026. 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?
Neurosensory outcome (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 19 Mar 2026.