RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the outcome of a new bone level tapered implant when inserted either following an immediate placement protocol or an early placement approach and restored with single crowns out of two different ceramic materials adhesively cemented on a titanium bonding base.

Official Title
-----------------
Randomized Controlled Clinical Trial of BLT Implants Used for Immediate vs Early Placement and Restored With Lithium-disilicate Glass Ceramic or Sintered Zirconia Crowns on Titanium Bonding Bases.

Conditions
-----------------
Tooth Loss, Dental Implant, Single-tooth

Intervention / Treatment
-----------------
* Procedure: Timepoint of Implant placement of Bonelevel tapered implants
* Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must require extraction and replacement of a tooth in the maxillary or mandibular anterior or premolar region with an implant reconstruction. ≥22 years of age Patient in a good general health Adequate bone quality and quantity for one-stage implant placement Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5) Adequate bone height of at least 1mm longer than the length of the study implant Capable of providing written informed consent. Obtained informed consent from the patient and committed to the study and the required follow-up visits. Exclusion Criteria: Patients with a high lip line / smile line Thin mucosal biotype Anatomically not sufficient bone volume or height at implant site to achieve primary stability of the implant Pronounced esthetic expectations Lack of keratinized mucosa at implant site (< 2mm oral and buccal) Women of childbearing potential with a positive urine pregnancy test Patients with inadequate oral hygiene or persistent intraoral infection Smokers exceeding 10 cigarettes / day, or equivalent; patients chewing tobacco Severe bruxism or clenching habits Presence a systemic disease or allergy (e.g. conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids, history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.) Presence or history of receiving intravenous or subcutaneous antiresorptive agents, such as bisphosphonates Presence of mucosal diseases (e.g. erosive lichen planus) in the localized area around the study implant Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, leucocyte dysfunction and deficiencies, neoplastic disease requiring the use of radiation or chemotherapy, etc. Patients with alcohol or drug abuse Participation in any other clinical trial (drug or device) less that 30 days before implant insertion

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the first phase, participants are randomized to receive implants either immediately or 8 weeks after tooth extraction. In a second phase, participants receive either a restoration out of one material or another, this also being randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate implant placement<br>Implant is placed immediately after tooth extraction. | Procedure: Timepoint of Implant placement of Bonelevel tapered implants<br>* Implant surgery on different time points<br>|
| Active Comparator: Delayed implant placement<br>Implant is placed 8 weeks after tooth extraction. | Procedure: Timepoint of Implant placement of Bonelevel tapered implants<br>* Implant surgery on different time points<br>|
| Experimental: Lithium disilicate crown<br>Crown out of Lithiumdisilicate is inserted onto the implant. | Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia<br>* Tooth restoration with a certain material<br>|
| Active Comparator: Zirconia Crown<br>Crown out of Zirconia is inserted onto the implant. | Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia<br>* Tooth restoration with a certain material<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Survival of the implant | 5 years | 
| Survival of the reconstructions | Survival of prosthetic reconstruction | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesial and distal bone levels | Peri-implant bone level changes | 5 years | 
| ISQ values | Measurement of ISQ values during implant surgery and at insertion of crown | 3 months | 
| Soft tissue volume | Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements. | 5 years | 
| Technical and biological outcomes of the restorations | Presence of fractures/chipping, retention loss, screw loosening | 5 years | 
| Recording the need of GBR procedures | Need of GBR procedure or not during surgery | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate implant placement, delayed implant placement, all-ceramic crown, monolithic restoration, titanium base