NCT03664219

Brief Summary

Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Status
unknown

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 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

September 5, 2018

Last Update Submit

September 7, 2018

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

  • Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area

    Assessing the sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area of sensation regaining

    Year

Secondary Outcomes (1)

  • Stability - Osstell device to assess the primary stability of placed dental implant

    Year

Study Arms (2)

isolation of IAN nerve with collagen membrane

ACTIVE COMPARATOR
Other: isolation of IAN from implant with collagen membrane

without isolation of the IAN with collagen

EXPERIMENTAL
Other: isolation of IAN from implant with collagen membrane

Interventions

isolation of IAN from implant with collagen membraneOTHER

comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant

isolation of IAN nerve with collagen membranewithout isolation of the IAN with collagen

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 intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.

You may not qualify if:

  • Presence pathological lesions
  • Heavy smokers more than 20 cigarettes per day .(24)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

ibrahim H garoushi

CONTACT

00201022478985garoushi.ibrahim@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Atrophied posterior mandible
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

September 10, 2018

Record last verified: 2018-09