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

Tooth Loss Clinical Trial

— BLT  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05079542
• Other study ID #: 15-117
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2015
• Est. completion date: March 3, 2025

Study information

• Verified date: October 2021
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 3, 2025
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant, Single-tooth
• Tooth Loss

Intervention

Procedure:
• Timepoint of Implant placement of Bonelevel tapered implants
Implant surgery on different time points

Combination Product:
• Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia
Tooth restoration with a certain material

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Outcome

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