NCT04546269

Brief Summary

Patients where placement of a single implant will be treated by senior dental students under close supervision of experienced spcialists. All implant treeatments will be categorized as "straight forward"according to the SAC classification. The patients will be randomized to have the implants placed using a fully guided or a convetionally guided protocol. Outcome parameters include accuracy of implant placement compared to an ideal implant position, patient- and student-reported outcome.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

August 28, 2020

Last Update Submit

September 5, 2020

Conditions

Jaw, Edentulous, Partially

Keywords

Implant DentistryGuided Implant PlacementSingle tooth implantComputer-guided surgery

Outcome Measures

Primary Outcomes (1)

  • Linear and angular accuracy of implant placement

    Linear (in mm) and angular (in degrees) deviations from an ideal implant position determined by three experienced investigators.

    1 year

Secondary Outcomes (1)

  • Patient-reported outcome

    1 year

Study Arms (2)

Fully-guided

EXPERIMENTAL

Single-tooth implant placed using a fully computer-guided approach

Procedure: Fully-guided vs. conventionally guided implant placement

Conventionally guided

ACTIVE COMPARATOR

Single-tooth implant placed using a conventionally guided approach

Procedure: Fully-guided vs. conventionally guided implant placement

Interventions

Fully-guided vs. conventionally guided implant placementPROCEDURE

Patients randomized to implant placement planned virtually based on a CBCT and a surface scan vs. implant placement based on a wax-up on gypsum casts

Conventionally guidedFully-guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of more than 18 years of age
  • Patients with a need of one or more single-tooth implants in the molar or the premolar region
  • Natural healthy neighboring teeth without need of restorations
  • Sufficient bone-volume for placing an implant without bone- or soft tissue augmentation

You may not qualify if:

  • Heavy smokers (more than 10 cigarettes per day)
  • Uncontrolled diabetes
  • Metabolic bone disorders
  • History of radiotherapy of the head and neck
  • Recent chemotherapy
  • Use of drugs influencing bone or soft tissue healing (e.g. high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
  • Additional oral surgery in the region of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, School of Dental Medicine

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assesor was blinded to the group allocation of the participant
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 11, 2020

Study Start

September 1, 2019

Primary Completion

August 1, 2020

Study Completion

February 1, 2021

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)