Immediate Loading and Fully Guided Surgery: Single Implants

Not Applicable

Completed

• Conditions: Osseointegration Failure of Dental Implant

• Registration Number: NCT04061694
• Lead Sponsor: Folktandvården Skåne AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2019-05
• Study Completion: 2019-08
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Results First Submitted: 2020-02-04
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Results First Posted: 2020-03-31
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MBL	12 months	Marginal bone loss MBL, measured in mm from implant abutment junction.
Pink Esthetic Score	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	12 months	White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.
Number of Participants With Implant Survival	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
Oral Health Impact Profile - 14	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.

Trial Locations

Locations (1)

Centre of Dental Specialist Care; 🇸🇪 Lund, Scania, Sweden