NCT07104994

Brief Summary

This study investigates the effects of inferior alveolar nerve lateralization on the post-implant insertion sensory outcome for patients with severe mandibular bone resorption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

July 22, 2025

Last Update Submit

August 1, 2025

Conditions

Sever Mandibular Bone ResorptionSensory DefectImplant Failure

Keywords

Inferior Alveolar NerveMandibular AtrophyDental ImplantAlveolar Ridge Resorption

Outcome Measures

Primary Outcomes (1)

  • Cone-beam Computed Tomography (CBCT)

    visualize the inferior alveolar canal (IAC) and assess the proximity of the implant to the nerve

    The implant's success rate was determined by primary stability during insertion, assessed by ratchet, and then confirmed by X-ray. CBCTs were taken at 3 months and 4 months after implant insertion to check for marginal bone loss.

Secondary Outcomes (1)

  • Subjective Function Score

    Neurosensory evaluation was carried out on the 1st and 7th postoperative day and every month thereafter for up to 6 months.

Study Arms (1)

Dental implant group

EXPERIMENTAL
Device: Dental implant

Interventions

Dental implantDEVICE

insertion of dental implants after surgical tranlocation of the inferior alveolar nerve.

Dental implant group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All other patients

You may not qualify if:

  • Patients with active infections, uncontrolled diabetes, history of radiotherapy, chemotherapy, or oral cancer surgery were excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Science and technology

Aden, Yemen

Location

Related Publications (1)

  • Hwaiti HS, Al-Rubidi YA, Al-Ashwal A, Al-Hadi Y, Al-Kibsi T, Al-Wesabi MA. Inferior alveolar nerve relocation and immediate dental implant placement in severely resorbed mandibles: a prospective clinical case series. BMC Oral Health. 2025 Dec 13. doi: 10.1186/s12903-025-07492-z. Online ahead of print.

    PMID: 41388273DERIVED

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 5, 2025

Study Start

June 11, 2024

Primary Completion

April 12, 2025

Study Completion

May 20, 2025

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations

YE(1)