CBCT-Based Safety Distance for Implant Placement Near the Inferior Alveolar Canal

NCT07363239 — Not yet recruiting, 100 participants, Cairo University

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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

Registry	NCT07363239
Status	Not yet recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Inferior Alveolar Approximation, Implants
Interventions	nerve approximation group (Other)
Dates	start 2027-01-20 (estimated), primary completion 2027-01-25 (estimated), completion 2027-01-30 (estimated), first posted 2026-01-23, last updated 2026-03-19

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
implants placed more than 2mm from the inferior alveolar canal		Other: nerve approximation group
Implant proximity < 2 mm

nerve approximation group (Other): implants placed with distance more than 2 mm from the inferior alveolar canal

+Outcome measures

Primary outcomes

Neurosensory outcome [6 months]: presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)

+Eligibility

Sex: All, ages: 21 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Age ≥ 21 years.
2. Implants placed in mandibular first/second premolar or molar positions (Froum et al., 2021).
3. Patients without neurosensory changes following implant placement and healing (Froum et al., 2021).
4. Patients with neurosensory changes after implant placement, including paresthesia, anesthesia, dysesthesia (and neuralgia where applicable) (Froum et al., 2021).

Exclusion Criteria:

1. Incomplete records preventing outcome ascertainment (Froum et al., 2021).
2. Refusal/unavailability of postoperative CBCT when clinically required for evaluation (Froum et al., 2021).
3. Poor-quality CBCT scans or scatter artifacts interfering with evaluation (Froum et al., 2021).
4. Contraindications for radiographs (e.g., pregnancy/breastfeeding) in cases where additional imaging would otherwise be clinically required (Froum et al., 2021).
5. Implants placed after mental foramen