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

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.

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.

Study Overview

• Status: Active, not recruiting
• 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Geneva, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Anticipated): March 3, 2025
• Study Completion (Anticipated): March 3, 2025

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: immediate implant placement; delayed implant placement; all-ceramic crown; monolithic restoration; titanium base
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 15-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No