NCT03730506

Brief Summary

Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology: Randomized Clinical Trial.

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
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

October 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

October 22, 2018

Last Update Submit

November 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees

    Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees to assess the accuracy of surgical guide

    one year

Study Arms (3)

CBCT

EXPERIMENTAL
Device: Intra oral scanner

IOS

EXPERIMENTAL
Device: Intra oral scanner

desktop scanner

ACTIVE COMPARATOR
Device: Intra oral scanner

Interventions

computer guided implant

Also known as: CBCT, desktop scanner
CBCTIOSdesktop scanner

Eligibility Criteria

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

You may qualify if:

  • partially edentulous patient.
  • Patients with bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.

You may not qualify if:

  • Completely edentulous patient or Free end saddle edentulous area.
  • Patients needing graft or sinus lifting with implant placement.
  • Patients with thin ridges.
  • Patients with systemic disease that may affect bone quality.
  • Patients with poor oral hygiene and active periodontal diseases.
  • Patient with limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 5, 2018

Study Start

November 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

November 5, 2018

Record last verified: 2018-11