Dental Implant FailedBLXNCT03720236
Peri-implant Tissues in BLX® Implants
A study testing Implant bed preparation protocol and Implant loading in people with Dental Implant Failed and Dental Prosthesis Failure, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Dental Prosthesis Failure
- What is being tested?
- Implant bed preparation protocol and Implant loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2018to 19 Jun 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients without systemic pathology
- Adult of age who agree to be part of the study and sign the informed consent.
- Patients smoking less than 5 cigarettes / day,
- Patients not being completely edentulous
- Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
- Area of mature bone healed at least 6 months post-extraction.
Show all 9Show fewer
- The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer.
- The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N.
- The placement of the implant must always be 4 mm below the future gingival margi
Who cannot join
- Immunosuppressed patients
- Aesthetic edentulous areas of 13-23 and 33-43
- Smokers of more than 5 cigarettes
- Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
- Index of bleeding greater than 30%
- Patients with less than 2 mm of keratinized gingiva
- Implants with ISQ index <55
- When a margin of 1 mm safety cannot be assumed to the inferior dental nerve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Being tested
- Implant bed preparation protocol, Implant loading
- Keywords
- dental implant, immediate loading, periimplant tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant bed preparation protocolProcedure or surgery
Also called IBP
This is the first surgical phase, we prepare the implant bed by using different increasing size drills.
Implant loadingProcedure or surgery
Also called IL
This is the second phase, based on prosthetic procedures, to design the crown over the dental implant
| Study group | Role | What they receive |
|---|---|---|
| Full preparation | Experimental | Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed. Receives: Procedure: Implant bed preparation protocol |
| Partial preparation | Experimental | Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out. Receives: Procedure: Implant bed preparation protocol |
| Deferred loading | Experimental | Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load. Receives: Procedure: Implant loading |
| Immediate load | Experimental | The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load. Receives: Procedure: Implant loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary stability of implants and peri-implant tissues
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
Measured: 12 months
Secondary outcomes (9)
Basal Peri-implant tissue level: implant stability
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will load the crowns in two different groups, code 1: loading the implants before 7 days after surgery; code 2: before 8 weeks after implant surgery. We will evaluate the stability at different moments, 8 weeks, 6 months and 12 months.The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).
Measured: 1 day
Basal Radiological Bone Implant level
At the moment of placing the implant a periapical radiography will be performed, considering this measure the basal radiological bone level (distance from the neck of the implant to the most crestal level of the alveolar bone). We will calculate the difference between the basal measure and the future measurements.
Measured: 1 day
Basal Peri-implant tissue level: probing depth
At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. We will calculate the difference between the basal measure and the future measurements.
Measured: 1 day
Radiological bone implant stability
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the bone level stability at 6 weeks in both groups. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.
Measured: 6 weeks
Peri-implant tissue stability: probing depth
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be gave by the differences between both measures, basal and actual in mm.
Measured: 6 weeks
Peri-implant tissue stability: ISQ
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be gave by the differences between both measures, basal and actual.
Measured: 6 weeks
Clinical tissue levels of definitive prostheses: probing depth
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the clinical probing depth, comparing with previous measurements.
Measured: 6 months
Clinical tissue levels of definitive prostheses: ISQ
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the implant stability through RFA, comparing with previous measurements.
Measured: 6 months
Radiological tissue levels of definitive prostheses: bone implant level
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the bone implant level by measuring the distance from de implant neck to the most apical inserted bone, comparing simultaneously with previous measurements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start2 Nov 2018
- Primary completion10 Jan 2019
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Manohay Dental SAU
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
- Investigators
- Mario Perez Sayans, PhD, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720236
- Sponsor's protocol ID
- CT-2018-05
- Acronym
- BLX
- Status last verified
- Jul 2020
- First submitted
- 5 Oct 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group (n=9)
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
- ClinicalTrials.gov ID
- NCT03720236
- Acronym / sponsor ID
- BLX / CT-2018-05
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Keywords
- dental implant, immediate loading, periimplant tissues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Manohay Dental SAU
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 25 Oct 2018 (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.
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full preparation | Experimental | Procedure: Implant bed preparation protocolGroup A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed. |
| Partial preparation | Experimental | Procedure: Implant bed preparation protocolGroup B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out. |
| Deferred loading | Experimental | Procedure: Implant loadingCode 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load. |
| Immediate load | Experimental | Procedure: Implant loadingThe code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients without systemic pathology
- Adult of age who agree to be part of the study and sign the informed consent.
- Patients smoking less than 5 cigarettes / day,
- Patients not being completely edentulous
- Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
Key exclusion criteria (8 listed)
- Immunosuppressed patients
- Aesthetic edentulous areas of 13-23 and 33-43
- Smokers of more than 5 cigarettes
- Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
- Index of bleeding greater than 30%
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 |
|---|---|---|
| Implant bed preparation protocolAlso: IBPThis is the first surgical phase, we prepare the implant bed by using different increasing size drills. | Procedure or surgery | Full preparation, Partial preparation |
| Implant loadingAlso: ILThis is the second phase, based on prosthetic procedures, to design the crown over the dental implant | Procedure or surgery | Deferred loading, Immediate load |
Primary outcome
Primary stability of implants and peri-implant tissues
Time frame: 12 months
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
9 secondary outcomes
Basal Peri-implant tissue level: implant stability
Time frame: 1 day
Basal Radiological Bone Implant level
Time frame: 1 day
Basal Peri-implant tissue level: probing depth
Time frame: 1 day
Radiological bone implant stability
Time frame: 6 weeks
Peri-implant tissue stability: probing depth
Time frame: 6 weeks
Peri-implant tissue stability: ISQ
Time frame: 6 weeks
Clinical tissue levels of definitive prostheses: probing depth
Time frame: 6 months
Clinical tissue levels of definitive prostheses: ISQ
Time frame: 6 months
Radiological tissue levels of definitive prostheses: bone implant level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- GI-1319Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group (n=9)
Related trials for Dental Implant Failed
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
Active, not recruiting
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Alveolar Bone Loss, Dental Implant Failed
Enrolling by invitationObservational study
Short Implants Produced by Additive Manufacturing in the Posterior Jaws: 3 Years of Follow-up
Periodontal Diseases, Dental Implant Failed
Recruiting
Effect of Systemic Vitamin D on Dental Implant Osseointegration
Dental Implant, Dental Implant Failed
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.
Mario Perez Sayans, PhD principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant bed preparation protocol and Implant loading in people with Dental Implant Failed and Dental Prosthesis Failure, run by University of Santiago de Compostela at 1 site in Spain.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary stability of implants and peri-implant tissues (time frame: 12 months). 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 7 Jul 2020.