Tooth LossBLTNCT05079542
RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.
A study testing Timepoint of Implant placement of Bonelevel tapered implants and Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia in people with Tooth Loss and Dental Implant, Single-tooth, run by University of Geneva, Switzerland.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Dental Implant, Single-tooth
- What is being tested?
- Timepoint of Implant placement of Bonelevel tapered implants and Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2015to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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.
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
- Being tested
- Timepoint of Implant placement of Bonelevel tapered implants, Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia
- Keywords
- immediate implant placement, delayed implant placement, all-ceramic crown, monolithic restoration, titanium base
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timepoint of Implant placement of Bonelevel tapered implantsProcedure or surgery
Implant surgery on different time points
Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconiaCombination product
Tooth restoration with a certain material
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement | Experimental | Implant is placed immediately after tooth extraction. Receives: Procedure: Timepoint of Implant placement of Bonelevel tapered implants |
| Delayed implant placement | Active comparator | Implant is placed 8 weeks after tooth extraction. Receives: Procedure: Timepoint of Implant placement of Bonelevel tapered implants |
| Lithium disilicate crown | Experimental | Crown out of Lithiumdisilicate is inserted onto the implant. Receives: Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia |
| Zirconia Crown | Active comparator | Crown out of Zirconia is inserted onto the implant. Receives: Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Survival of the implant
Measured: 5 years
Survival of the reconstructions
Survival of prosthetic reconstruction
Measured: 5 years
Secondary outcomes (5)
Mesial and distal bone levels
Peri-implant bone level changes
Measured: 5 years
ISQ values
Measurement of ISQ values during implant surgery and at insertion of crown
Measured: 3 months
Soft tissue volume
Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements.
Measured: 5 years
Technical and biological outcomes of the restorations
Presence of fractures/chipping, retention loss, screw loosening
Measured: 5 years
Recording the need of GBR procedures
Need of GBR procedure or not during surgery
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start5 Oct 2015
- Primary completion3 Mar 2025 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. dent. Malin Strasding, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079542
- Sponsor's protocol ID
- 15-117
- Acronym
- BLT
- Status last verified
- Oct 2021
- First submitted
- 17 Mar 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05079542
- Acronym / sponsor ID
- BLT / 15-117
- Conditions
- Tooth Loss, Dental Implant, Single-tooth
- Keywords
- immediate implant placement, delayed implant placement, all-ceramic crown, monolithic restoration, titanium base
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement | Experimental | Procedure: Timepoint of Implant placement of Bonelevel tapered implantsImplant is placed immediately after tooth extraction. |
| Delayed implant placement | Active comparator | Procedure: Timepoint of Implant placement of Bonelevel tapered implantsImplant is placed 8 weeks after tooth extraction. |
| Lithium disilicate crown | Experimental | Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconiaCrown out of Lithiumdisilicate is inserted onto the implant. |
| Zirconia Crown | Active comparator | Combination Product: Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconiaCrown out of Zirconia is inserted onto the implant. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (15 listed)
- Patients with a high lip line / smile line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timepoint of Implant placement of Bonelevel tapered implantsImplant surgery on different time points | Procedure or surgery | Delayed implant placement, Immediate implant placement |
| Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconiaTooth restoration with a certain material | Combination product | Lithium disilicate crown, Zirconia Crown |
Primary outcome
Implant survival
Time frame: 5 years
Survival of the implant
Survival of the reconstructions
Time frame: 5 years
Survival of prosthetic reconstruction
5 secondary outcomes
Mesial and distal bone levels
Time frame: 5 years
ISQ values
Time frame: 3 months
Soft tissue volume
Time frame: 5 years
Technical and biological outcomes of the restorations
Time frame: 5 years
Recording the need of GBR procedures
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Timepoint of Implant placement of Bonelevel tapered implants and Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia in people with Tooth Loss and Dental Implant, Single-tooth, run by University of Geneva, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.