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

Dental Implant Failed Clinical Trial

— 1T1T  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02898311
• Other study ID #: TT001
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: September 2021

Study information

• Verified date: May 2019
• Source: University of Liege
• Contact: Amélie Mainjot
• Phone: 003242703131
• Email: a.mainjot[@]chu.ulg.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: May 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Dental Implant Failed
• Dental Prosthesis Failure
• Prosthesis Failure
• Tooth Loss

Intervention

Device:
• immediate loading of posterior implants with chairside CAD-CAM composite crown

Locations

Country	Name	City	State
Belgium	Liege University Hospital Center of Liege	Liège
Belgium	University Hospital Center of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant complication rate		6 months
Primary	Prosthesis complication rate		6 months
Secondary	Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.		1 day
Secondary	Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire		1 day
Secondary	Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire		6 months