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

NCT05079542 | Unknown

• 1 other identifier: 15-117
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Loss; Dental Implant, Single-tooth

Keywords

immediate implant placement; delayed implant placement; all-ceramic crown; monolithic restoration; titanium base

Outcome Measures

Primary Outcomes (2)

• Implant survival

  Survival of the implant

  5 years

• Survival of the reconstructions

  Survival of prosthetic reconstruction

  5 years

Secondary Outcomes (5)

• Mesial and distal bone levels

  5 years

• ISQ values

  3 months

• Soft tissue volume

  5 years

• Technical and biological outcomes of the restorations

  5 years

• Recording the need of GBR procedures

  8 weeks

Study Arms (4)

Immediate implant placement

EXPERIMENTAL

Implant is placed immediately after tooth extraction.

Procedure: Timepoint of Implant placement of Bonelevel tapered implants

Delayed implant placement

ACTIVE COMPARATOR

Implant is placed 8 weeks after tooth extraction.

Procedure: Timepoint of Implant placement of Bonelevel tapered implants

Lithium disilicate crown

EXPERIMENTAL

Crown out of Lithiumdisilicate is inserted onto the implant.

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

Zirconia Crown

ACTIVE COMPARATOR

Crown out of Zirconia is inserted onto the implant.

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

Interventions

Timepoint of Implant placement of Bonelevel tapered implants PROCEDURE

Implant surgery on different time points

Delayed implant placement; Immediate implant placement

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia COMBINATION_PRODUCT

Tooth restoration with a certain material

Lithium disilicate crown; Zirconia Crown

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

MeSH Terms

Conditions

Tooth Loss

Interventions

zirconium oxide

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: October 15, 2021
• Study Start: October 5, 2015
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: October 15, 2021

Record last verified: 2021-10