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

NCT ID: NCT05079542

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-05

Study Completion Date

2025-03-03

Brief Summary

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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

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Conditions

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Tooth Loss Dental Implant, Single-tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate implant placement

Implant is placed immediately after tooth extraction.

Group Type EXPERIMENTAL

Timepoint of Implant placement of Bonelevel tapered implants

Intervention Type PROCEDURE

Implant surgery on different time points

Delayed implant placement

Implant is placed 8 weeks after tooth extraction.

Group Type ACTIVE_COMPARATOR

Timepoint of Implant placement of Bonelevel tapered implants

Intervention Type PROCEDURE

Implant surgery on different time points

Lithium disilicate crown

Crown out of Lithiumdisilicate is inserted onto the implant.

Group Type EXPERIMENTAL

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

Intervention Type COMBINATION_PRODUCT

Tooth restoration with a certain material

Zirconia Crown

Crown out of Zirconia is inserted onto the implant.

Group Type ACTIVE_COMPARATOR

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

Intervention Type COMBINATION_PRODUCT

Tooth restoration with a certain material

Interventions

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Timepoint of Implant placement of Bonelevel tapered implants

Implant surgery on different time points

Intervention Type PROCEDURE

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

Tooth restoration with a certain material

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. dent. Malin Strasding

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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15-117

Identifier Type: -

Identifier Source: org_study_id