NCT07008534

Brief Summary

The aim of this study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main disadvantage of this technique \& provide a reliable,saving time - computer guided simultaneous implant placement- and improved technique.

Trial Health

65
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Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jul 2025

Typical duration for not_applicable

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

Study Progress49%
Jul 2025Apr 2027

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

May 29, 2025

Last Update Submit

July 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical neurosensory assessment of inferior alveolar nerve.

    6 months

Study Arms (2)

Computer guided immediate implant placement & IAN lateralization

ACTIVE COMPARATOR

Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.

Procedure: Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.

computer guided immediate implant placement & IAN lateralization with Sticky bone

EXPERIMENTAL

Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization with sticky bone

Procedure: IAN lateralization with computer-guided immediate implant placement using Sticky Bone

Interventions

Standard procedure without Sticky Bone application.

Computer guided immediate implant placement & IAN lateralization

The same as the control with additional application of Sticky Bone as an insulator for enhanced neurosensory disfunction

computer guided immediate implant placement & IAN lateralization with Sticky bone

Eligibility Criteria

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

You may qualify if:

  • Adult patients requiring oral rehabilitation with dental implants in vertically atrophied
  • Posterior mandibular region, less than 8mm of bone above the mandibular canal.
  • Patients should be free from any systemic conditions that may affect normal healing.
  • Absence of any pathological conditions involving mandibular bones.

You may not qualify if:

  • Patients under bisphosphonates treatment.
  • Any contraindication for general anaesthesia.
  • Osteoporotic patients.
  • Patients with neurological disorders (neuralgias, Parkinson' s disease).
  • Patients with systematic disease that may complicate healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07