NCT03669510

Brief Summary

: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

September 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

September 11, 2018

Last Update Submit

April 17, 2024

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

  • Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10)

    assessing the sensation regaining over time subjective (a scale 1-10 )

    1 year

Secondary Outcomes (1)

  • Implant stability

    At the placement and after exposure ( up to 6 months )

Study Arms (2)

computer gaiuded IAN

ACTIVE COMPARATOR

Computer guided surgical technique

Other: computer guided IAN lateralization surgical technique

Classical technique

EXPERIMENTAL

Non computer guided surgical technique

Other: computer guided IAN lateralization surgical technique

Interventions

computer guided IAN lateralization surgical techniqueOTHER

Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique

Classical techniquecomputer gaiuded IAN

Eligibility Criteria

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

You may qualify if:

  • Adult patients with with atrophied posterior mandibular ridge
  • both sexes
  • NO intra oral soft and hard tissue pathology
  • NO systematic that contraindicate implant placement

You may not qualify if:

  • Presence pathological lesion
  • Heavy smokers more than 20 cigarettes per day.
  • patients with systemic disease that may affect normal healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: atrophic posterior mandible requiring nerve lateralization
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 13, 2018

Study Start

January 1, 2019

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

EG(1)