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OpenTrials
Completed

NCT Number: NCT04061694

Immediate Loading and Fully Guided Surgery: Single Implants

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.

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Key information

Conditions

Osseointegration Failure of Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Dental Specialist Care

Lund, Skåne County, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate loading, fully guided surgery and 3D printed restoration

Procedure

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

Immediate loading

Procedure

Only subjected to immediate loading. Conventional procedure.

Primary outcomes

  1. 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

  2. MBL

    Time frame: 12 months

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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Folktandvården Skåne AB

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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