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

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:

  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

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.

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

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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