NCT04061694

Brief Summary

To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 31, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

August 16, 2019

Results QC Date

February 4, 2020

Last Update Submit

March 30, 2020

Conditions

Osseointegration Failure of Dental Implant

Outcome Measures

Primary Outcomes (5)

  • Number of Participants With Implant Survival

    Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction

    12 months

  • MBL

    Marginal bone loss MBL, measured in mm from implant abutment junction.

    12 months

  • Pink Esthetic Score

    Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.

    12 months

  • White Esthetic Score

    White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.

    12 months

  • Oral Health Impact Profile - 14

    Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.

    12 months

Study Arms (2)

Digital Immediate loading

EXPERIMENTAL

Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing

Procedure: Immediate loading, fully guided surgery and 3D printed restoration

Immediate loading

OTHER

Historic cohort subjected to immediate loading

Procedure: Immediate loading

Interventions

Immediate loading, fully guided surgery and 3D printed restorationPROCEDURE

Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.

Digital Immediate loading
Immediate loadingPROCEDURE

Only subjected to immediate loading. Conventional procedure.

Immediate loading

Eligibility Criteria

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

You may qualify if:

  • at least 18 years of age who had signed an informed consent
  • in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.

You may not qualify if:

  • general contraindications for oral surgery
  • patients with inadequate oral hygiene
  • need for bone grafting or ridge augmentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Dental Specialist Care

Lund, Skåne County, Sweden

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Results Point of Contact

Title
Björn Gjelvold
Organization
Folktandvården Skåne AB
bjorn.gjelvold@gmail.com
+46709467870

Study Officials

  • Ann Wennerberg, PhD

    Göteborg University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Oral Prosthodontics

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 20, 2019

Study Start

November 1, 2016

Primary Completion

May 1, 2019

Study Completion

August 1, 2019

Last Updated

March 31, 2020

Results First Posted

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)