Immediate Loading and Fully Guided Surgery: Single Implants

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2019

Interventions

  • 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.
  • Procedure: Immediate loading
    • Only subjected to immediate loading. Conventional procedure.

Arms, Groups and Cohorts

  • 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
  • Other: Immediate loading
    • Historic cohort subjected to immediate loading

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • MBL
    • Time Frame: 12 months
    • Marginal bone loss MBL, measured in mm from implant abutment junction.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Folktandvården Skåne AB
  • Provider of Information About this Clinical Study
    • Principal Investigator: Björn Gjelvold, Specialist in Oral Prosthodontics – Folktandvården Skåne AB
  • Overall Official(s)
    • Ann Wennerberg, PhD, Study Director, Göteborg University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.