Immediate Loading and Fully Guided Surgery: Single Implants

March 30, 2020 updated by: Björn Gjelvold, Folktandvården Skåne AB

Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Scania
      • Lund, Scania, Sweden
        • Centre of Dental Specialist Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Immediate loading
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
Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
Other: Immediate loading
Historic cohort subjected to immediate loading
Procedure: Immediate loading
Only subjected to immediate loading. Conventional procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Implant Survival
Time Frame: 12 months
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
Time Frame: 12 months
Marginal bone loss MBL, measured in mm from implant abutment junction.
12 months
Pink Esthetic Score
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Folktandvården Skåne AB

Investigators

  • Study Director: Ann Wennerberg, PhD, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DIL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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