- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363239
CBCT-Based Safety Distance for Implant Placement Near the Inferior Alveolar Canal
March 17, 2026 updated by: Ghada Adayil, Cairo University
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
implants placed more than 2mm from the inferior alveolar canal
|
implants placed with distance more than 2 mm from the inferior alveolar canal
|
|
Implant proximity < 2 mm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurosensory outcome
Time Frame: 6 months
|
presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 20, 2027
Primary Completion (Estimated)
January 25, 2027
Study Completion (Estimated)
January 30, 2027
Study Registration Dates
First Submitted
January 15, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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