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

Not Applicable

Active, not recruiting

• Conditions: Tooth Loss; Dental Implant, Single-tooth
• Interventions: Procedure: Timepoint of Implant placement of Bonelevel tapered implants; Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

• Registration Number: NCT05079542
• Lead Sponsor: University of Geneva, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Study First Submitted: 2021-03-17
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2025-03-03
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant placement	Timepoint of Implant placement of Bonelevel tapered implants	Implant is placed immediately after tooth extraction.
Zirconia Crown	Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia	Crown out of Zirconia is inserted onto the implant.
Delayed implant placement	Timepoint of Implant placement of Bonelevel tapered implants	Implant is placed 8 weeks after tooth extraction.
Lithium disilicate crown	Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia	Crown out of Lithiumdisilicate is inserted onto the implant.

Primary Outcome Measures

Name	Time	Method
Implant survival	5 years	Survival of the implant
Survival of the reconstructions	5 years	Survival of prosthetic reconstruction

Secondary Outcome Measures

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