Clinical trial NCT05079542: RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Dental Implant, Single-tooth
Keywords: immediate implant placement
delayed implant placement
all-ceramic crown
monolithic restoration
titanium base
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant survival
timeFrame: 5 years
measure: Survival of the reconstructions
timeFrame: 5 years
Secondary outcomes:
measure: Mesial and distal bone levels
timeFrame: 5 years
measure: ISQ values
timeFrame: 3 months
measure: Soft tissue volume
timeFrame: 5 years
measure: Technical and biological outcomes of the restorations
timeFrame: 5 years
measure: Recording the need of GBR procedures
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: