CBCT-Based Safety Distance for Implant Placement Near the... | NCT07363239

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

NCT07363239

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Inferior Alveolar Approximation
Implants

Interventions

nerve approximation group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2027Estimated

Primary Completion Date

Jan 25, 2027Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Jan 15, 2026

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nerve approximation group	Other	implants placed with distance more than 2 mm from the inferior alveolar canal	implants placed more than 2mm from the inferior alveolar canal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurosensory outcome	presence/absence of neurosensory changes after implant placement, classified as reported in records (none, paresthesia, anesthesia, dysesthesia, neuralgia)	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample