Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02898311
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Mainjot Amélie, University Hospital of Liege

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.


Condition or disease Intervention/treatment Phase
Dental Implant Failed Dental Prosthesis Failure Device: immediate loading of posterior implants with chairside CAD-CAM composite crown Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
Study Start Date : July 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs




Primary Outcome Measures :
  1. Implant complication rate [ Time Frame: 6 months ]
  2. Prosthesis complication rate [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898311


Contacts
Layout table for location contacts
Contact: Amélie Mainjot 003242703131 a.mainjot@chu.ulg.ac.be
Contact: France Lambert 00324242 54 27 france.lambert@chu.ulg.ac.be

Locations
Layout table for location information
Belgium
Liege University Hospital Center of Liege Recruiting
Liège, Belgium, 4000
University Hospital Center of Liège Recruiting
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege

Layout table for additonal information
Responsible Party: Mainjot Amélie, Associate professor- Head of Clinic, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT02898311     History of Changes
Other Study ID Numbers: TT001
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Mainjot Amélie, University Hospital of Liege:
CAD-CAM
composite dental resin
Immediate dental implant loading

Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Loss
Anodontia
Prosthesis Failure
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Postoperative Complications
Pathologic Processes