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

University of Geneva, Switzerland

Status: Active, not recruiting

Conditions: Tooth Loss; Dental Implant, Single-tooth

Treatments: Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia; Procedure: Timepoint of Implant placement of Bonelevel tapered implants

Study type: Interventional

Funder types: Other

Identifiers

NCT05079542

15-117

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Immediate implant placement

Experimental group

Description:

Implant is placed immediately after tooth extraction.

Treatment:

Procedure: Timepoint of Implant placement of Bonelevel tapered implants

Delayed implant placement

Active Comparator group

Description:

Implant is placed 8 weeks after tooth extraction.

Treatment:

Procedure: Timepoint of Implant placement of Bonelevel tapered implants

Lithium disilicate crown

Experimental group

Description:

Crown out of Lithiumdisilicate is inserted onto the implant.

Treatment:

Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

Zirconia Crown

Active Comparator group

Description:

Crown out of Zirconia is inserted onto the implant.

Treatment:

Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia