NCT03661658

Brief Summary

Assess the long term stability of short dental implants in comparison to standard implants inserted simultaneously with inferior alveolar nerve lateralization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

September 2, 2018

Last Update Submit

September 5, 2018

Conditions

Primary Stability of the ImplantsMarginal Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Primary stability

    measuring the primary stability using the osstel

    3 months

Secondary Outcomes (1)

  • Marginal bone loss

    3 months

Study Arms (2)

Inferior alveolar nerve lateralization with implant placement

ACTIVE COMPARATOR
Procedure: Inferior alveolar nerve lateralization with simultaneous implant placement

Using short dental implant with atrophic mandible

EXPERIMENTAL
Procedure: Using short dental implant

Interventions

Using short dental implantPROCEDURE

Using short dental implant for patients with atrophic posterior mandible.

Using short dental implant with atrophic mandible
Inferior alveolar nerve lateralization with simultaneous implant placementPROCEDURE

Inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible.

Inferior alveolar nerve lateralization with implant placement

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients with edentulous posterior mandible.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.
  • Residual alveolar bone width longer than 6 mm height (7-9 mm).

You may not qualify if:

  • Presence of fenestrations or dehiscence of the residual ridge.
  • 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

Study Sites (1)

Ehab Ahmed Shams

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist-Master student

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 7, 2018

Study Start

September 1, 2018

Primary Completion

February 1, 2019

Study Completion

June 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Locations

EG(1)