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

NCT02898311 | Unknown

• 1 other identifier: TT001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Implant Failed; Dental Prosthesis Failure

Keywords

CAD-CAM; composite dental resin; Immediate dental implant loading

Outcome Measures

Primary Outcomes (2)

• Implant complication rate

  6 months

• Prosthesis complication rate

  6 months

Secondary Outcomes (3)

• 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

Interventions

immediate loading of posterior implants with chairside CAD-CAM composite crown DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.
• Sites treated with socket preservation techniques
• Untreated local inflammation
• Mucosal diseases or oral lesions
• History of local irradiation therapy in Head-Neck area

Sponsors & Collaborators

• University of Liege: lead

Study Sites (2)

Liege University Hospital Center of Liege

Liège, 4000, Belgium

RECRUITING

University Hospital Center of Liège

Liège, 4000, Belgium

RECRUITING

Central Study Contacts

Amélie Mainjot

CONTACT

003242703131; a.mainjot@chu.ulg.ac.be

France Lambert

CONTACT

00324242 54 27; france.lambert@chu.ulg.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor- Head of Clinic

Study Record Dates

• First Submitted: August 27, 2016
• First Posted: September 13, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2021
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

BE (2)