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

NCT ID: NCT02898311

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

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

Intervention Type: DEVICE

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Mainjot Amélie

Associate professor- Head of Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liege University Hospital Center of Liege

Liège, , Belgium

Site Status: RECRUITING

University Hospital Center of Liège

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Amélie Mainjot

Role: CONTACT

a.mainjot@chu.ulg.ac.be

003242703131

France Lambert

Role: CONTACT

france.lambert@chu.ulg.ac.be

00324242 54 27

Other Identifiers

TT001

Identifier Type: -

Identifier Source: org_study_id