NCT07363239

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Jan 2027

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
12 months until next milestone

Study Start

First participant enrolled

January 20, 2027

Expected
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2027

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

March 19, 2026

Status Verified

January 1, 2026

Enrollment Period

5 days

First QC Date

January 15, 2026

Last Update Submit

March 17, 2026

Conditions

Inferior Alveolar ApproximationImplants

Keywords

inferior alveolar nerveimplants

Outcome Measures

Primary Outcomes (1)

  • Neurosensory outcome

    presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)

    6 months

Study Arms (2)

implants placed more than 2mm from the inferior alveolar canal

Other: nerve approximation group

Implant proximity < 2 mm

Interventions

nerve approximation groupOTHER

implants placed with distance more than 2 mm from the inferior alveolar canal

implants placed more than 2mm from the inferior alveolar canal

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start (Estimated)

January 20, 2027

Primary Completion (Estimated)

January 25, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-01