Immediate Loading and Fully Guided Surgery: Single Implants

Osseointegration Failure of Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061694
• Other study ID #: DIL001
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2019

Study information

• Verified date: March 2020
• Source: Fölktandvården Skåne AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osseointegration Failure of Dental Implant

Intervention

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

Locations

Country	Name	City	State
Sweden	Centre of Dental Specialist Care	Lund	Scania

Sponsors (1)

Lead Sponsor	Collaborator
Fölktandvården Skåne AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	MBL	Marginal bone loss MBL, measured in mm from implant abutment junction.	12 months
Primary	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
Primary	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
Primary	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