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

Primary Purpose

Tooth Loss, Dental Implant, Single-tooth

Status

Active

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Timepoint of Implant placement of Bonelevel tapered implants

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring immediate implant placement, delayed implant placement, all-ceramic crown, monolithic restoration, titanium base

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Immediate implant placement

Delayed implant placement

Lithium disilicate crown

Zirconia Crown

Arm Description

Implant is placed immediately after tooth extraction.

Implant is placed 8 weeks after tooth extraction.

Crown out of Lithiumdisilicate is inserted onto the implant.

Crown out of Zirconia is inserted onto the implant.

Outcomes

Primary Outcome Measures

Implant survival

Survival of the implant

Survival of the reconstructions

Survival of prosthetic reconstruction

Secondary Outcome Measures

Mesial and distal bone levels

Peri-implant bone level changes

ISQ values

Measurement of ISQ values during implant surgery and at insertion of crown

Soft tissue volume

Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements.

Technical and biological outcomes of the restorations

Presence of fractures/chipping, retention loss, screw loosening

Recording the need of GBR procedures

Need of GBR procedure or not during surgery

Full Information

NCT ID

NCT05079542

First Posted

March 17, 2021

Last Updated

October 3, 2021

Sponsor

University of Geneva, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT05079542

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 5, 2015 (Actual)

Primary Completion Date

March 3, 2025 (Anticipated)

Study Completion Date

March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss, Dental Implant, Single-tooth

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate implant placement

Arm Type

Experimental

Arm Description

Implant is placed immediately after tooth extraction.

Arm Title

Delayed implant placement

Arm Type

Active Comparator

Arm Description

Implant is placed 8 weeks after tooth extraction.

Arm Title

Lithium disilicate crown

Arm Type

Experimental

Arm Description

Crown out of Lithiumdisilicate is inserted onto the implant.

Arm Title

Zirconia Crown

Arm Type

Active Comparator

Arm Description

Crown out of Zirconia is inserted onto the implant.

Intervention Type

Procedure

Intervention Name(s)

Timepoint of Implant placement of Bonelevel tapered implants

Intervention Description

Implant surgery on different time points

Intervention Type

Combination Product

Intervention Name(s)

Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia

Intervention Description

Tooth restoration with a certain material

Primary Outcome Measure Information:

Title

Implant survival

Description

Survival of the implant

Time Frame

5 years

Title

Survival of the reconstructions

Description

Survival of prosthetic reconstruction

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Mesial and distal bone levels

Description

Peri-implant bone level changes

Time Frame

5 years

Title

ISQ values

Description

Measurement of ISQ values during implant surgery and at insertion of crown

Time Frame

3 months

Title

Soft tissue volume

Description

Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements.

Time Frame

5 years

Title

Technical and biological outcomes of the restorations

Description

Presence of fractures/chipping, retention loss, screw loosening

Time Frame

5 years

Title

Recording the need of GBR procedures

Description

Need of GBR procedure or not during surgery

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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