One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series (1T1T)

This study evaluates the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years.

Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The time and cost benefit of the presented digital workflow, as patient centered outcomes will also be evaluated.

Study Overview

• Status: Unknown
• Conditions: Dental Implant Failed; Dental Prosthesis Failure
• Intervention / Treatment: Device: immediate loading of posterior implants with chairside CAD-CAM composite crown

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • Liege University Hospital Center of Liege
  • Liège, Belgium, 4000
    • Recruiting
    • University Hospital Center of Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

0 In good systemic health (ASA I/ II)

• Present with no contra indication against oral surgical interventions
• The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
• At least 8 mm of bone in the vertical dimension
• At least 6 mm of bone in the bucco-lingual dimension.
• No need for bone augmentation procedure in any of the dimensions
• Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria

• Autoimmune disease requiring medical treatment
• Medical conditions requiring prolonged use of steroids
• Use of Bisphosphonate intravenously or more then ˃ 3 years of oral use
• Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
• Current pregnancy or breastfeeding women
• Alcoholism or chronically drug abuse
• Immunocompromised patients
• Uncontrolled Diabetes
• Smokers
• Prisoners
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Local exclusion criteria:

• Sites treated with socket preservation techniques
• Untreated local inflammation
• Mucosal diseases or oral lesions
• History of local irradiation therapy in Head-Neck area
• Persistent intraoral infection (periodontitis, caries, …)
• Patients inadequate oral hygiene or unmotivated for normal home care.
• Removable prosthesis as an antagonist of the teeth to be replaced or absence of antagonistic teeth
• Severe bruxism or parafunctions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Implant complication rate	6 months
Prosthesis complication rate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.	1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire	1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire	6 months

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 27, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: CAD-CAM; Immediate dental implant loading; composite dental resin
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: TT001