Back to resultsOne-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series (1T1T)
Primary Purpose
Dental Implant Failed, Dental Prosthesis Failure
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
immediate loading of posterior implants with chairside CAD-CAM composite crown
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant Failed focused on measuring CAD-CAM, composite dental resin, Immediate dental implant loading
Eligibility Criteria
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
Sites / Locations
- Liege University Hospital Center of LiegeRecruiting
- University Hospital Center of LiègeRecruiting
Outcomes
Primary Outcome Measures
Implant complication rate
Prosthesis complication rate
Secondary Outcome Measures
Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02898311
Brief Title
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
Acronym
1T1T
Official Title
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Dental Prosthesis Failure
Keywords
CAD-CAM, composite dental resin, Immediate dental implant loading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
immediate loading of posterior implants with chairside CAD-CAM composite crown
Primary Outcome Measure Information:
Title
Implant complication rate
Time Frame
6 months
Title
Prosthesis complication rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.
Time Frame
1 day
Title
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Time Frame
1 day
Title
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Mainjot
Phone
003242703131
Email
a.mainjot@chu.ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
France Lambert
Phone
00324242 54 27
Email
france.lambert@chu.ulg.ac.be
Facility Information:
Facility Name
Liege University Hospital Center of Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Center of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
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