Clinical trial NCT02898311: One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
Official title: One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Failed
Dental Prosthesis Failure
Keywords: CAD-CAM
composite dental resin
Immediate dental implant loading
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-09-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant complication rate
timeFrame: 6 months
measure: Prosthesis complication rate
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.
timeFrame: 1 day
measure: Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
timeFrame: 1 day
measure: Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Liege University Hospital Center of Liege
city: Liège
country: Belgium
facility: University Hospital Center of Liège
Study officials:
References: