Immediate Placement of Straumann BLX Implants in Molar Extraction SocketsPhase 2NCT04327284
Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
A Phase 2 study testing Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm) and Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm) in people with Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets, run by Ahmad Kutkut at 1 site in United States.
Trial summary
The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. Read more about this study
- Who is it for?
- Ages 22 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets
- What is being tested?
- Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm) and Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jun 2024
- Phase
- Phase 2
- 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 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- good general health.
- at least one nonrestorable more indicated for extraction and immediate or delayed implant placement
Who cannot join
- undergo oral surgery procedures
- smokers
- women who are (or become) pregnant (or are breastfeeding)
- subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.
Read the detailed description
Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.
15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:
Test Group (n=15):
The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).
Control Group (n=15):
The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm).
Subject Recruitment Methods and Privacy:
Subjects who seek implant treatment in University of Kentucky, College of Dentistry clinics. Implant clinics is referral base clinic. Once a subject is referred to extract a nonrestorable molar tooth and be replaced with an implant, potential subjects will be informed with the study. If subjects decide to be part of the study, informed consent will be signed prior to screening visit.
Informed Consent Process:
The research study will be conducted at the facilities of University of Kentucky, College of Dentistry after approval by the Institutional Review Board. All members of the research team received training in human subject protection. After each patient has been given verbal and written information describing the nature of the study, informed consent will be obtained before he or she can enter the study. A copy of the consent form will be given to the patient and another retained by the investigator. Patients will not be screened until an informed consent has been obtained.
- Being tested
- Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm), Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)
- Keywords
- Immediate, Molar, Extraction, Sockets, Bone Graft, Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm)Device
At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow.
The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.
Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)Device
At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow.
The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm). Receives: Device: Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm) |
| Control group | Active comparator | The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm). Receives: Device: Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Examination: Implant Success and Failure Criteria
Implant success is defined by clinical and radiographic parameters. The success criteria for the implants will be (1) no radiolucency around the implant, (2) no mobility, and (3) no suppuration, pain, or ongoing pathologic process. Implants that do not meet the above criteria fall under the implant failure category. Success rate percentage will be based on clinical and radiographic assessment per implant site.
Measured: 12 months
Radiographic Examination
Regional Cone Beam CT scan imaging for implant sites will be made for research purposes at baseline after implant placement, and 12 months follow up visits. These images are the only way to provide 3 dimensional view of bone around implants (Mesial-Distal, Buccal-Lingual). Marginal bone level changes will be recorded on the mid-mesial, mid-distal, mid-labial, and mid-lingual sites for each implant from the reference line (RL) of the implant platform immediately after implant placement and 12 months follow up visits. All measurements will be made utilizing a coDiagnostiX software used at University of Kentucky College of Dentistry. Marginal bone changes around implants for each site (i.e., Mesial, Distal, Buccal, and Lingual) will be digitally analyzed using the software and statistically analyzed and compared between groups utilizing SPSS software.
Measured: 12 months
Osstell Value Assessment
Osstell® RFA (Resonance Frequency Analysis) values will be recorded immediately after implant placement, 3 months, and 12 months follow up visits to report implant stability during the healing time. RFA values for each implant will be statistically analyzed and compared between and within groups utilizing SPSS software.
Measured: 12 months
3D Printed Models Assessment
3D printed models will be generated from intraoral scan prior to baseline extraction visit and 3, 12 months follow up. Volumetric changes will be measured and analyzed digitally with compare software.
Measured: 12 months
Photographic Documentation
Photographic documentation will be made using a digital camera for each visit to clinically evaluate the peri-implant tissue healing response around implants with immediate vs. early placements.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Why it stopped: Research cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Placement of Straumann BLX Implants in Molar Extraction SocketsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a single site, randomized, controlled, prospective, and parallel arms study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Kutkut
- Sponsor type
- University, hospital or other
- Collaborators
- Straumann USA
- Responsible party
- Sponsor-investigator, Ahmad Kutkut, University of Kentucky
- Investigators
- Ahmad KutKut, DDS, MS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327284
- Sponsor's protocol ID
- 55344
- Status last verified
- May 2023
- First submitted
- 26 Mar 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
- ClinicalTrials.gov ID
- NCT04327284
- Acronym / sponsor ID
- 55344
- Keywords
- Immediate, Molar, Extraction, Sockets, Bone Graft, Dental Implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ahmad KutkutUniversity, hospital or other
- Collaborators
- Straumann USA
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 31 Mar 2020 (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 aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.
Detailed description
Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.
15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:
Test Group (n=15):
The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).
Control Group (n=15):
The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm).
Subject Recruitment Methods and Privacy:
Subjects who seek implant treatment in University of Kentucky, College of Dentistry clinics. Implant clinics is referral base clinic. Once a subject is referred to extract a nonrestorable molar tooth and be replaced with an implant, potential subjects will be informed with the study. If subjects decide to be part of the study, informed consent will be signed prior to screening visit.
Informed Consent Process:
The research study will be conducted at the facilities of University of Kentucky, College of Dentistry after approval by the Institutional Review Board. All members of the research team received training in human subject protection. After each patient has been given verbal and written information describing the nature of the study, informed consent will be obtained before he or she can enter the study. A copy of the consent form will be given to the patient and another retained by the investigator. Patients will not be screened until an informed consent has been obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a single site, randomized, controlled, prospective, and parallel arms study.
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm)The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm). |
| Control group | Active comparator | Device: Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm). |
Who may qualify
- Ages
- 22 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 22 years of age or older
- good general health.
- at least one nonrestorable more indicated for extraction and immediate or delayed implant placement
Key exclusion criteria (4 listed)
- undergo oral surgery procedures
- smokers
- women who are (or become) pregnant (or are breastfeeding)
- subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)
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 |
|---|---|---|
| Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm)At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months. | Device | test group |
| Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months. | Device | Control group |
Primary outcome
Clinical Examination: Implant Success and Failure Criteria
Time frame: 12 months
Implant success is defined by clinical and radiographic parameters. The success criteria for the implants will be (1) no radiolucency around the implant, (2) no mobility, and (3) no suppuration, pain, or ongoing pathologic process. Implants that do not meet the above criteria fall under the implant failure category. Success rate percentage will be based on clinical and radiographic assessment per implant site.
Radiographic Examination
Time frame: 12 months
Regional Cone Beam CT scan imaging for implant sites will be made for research purposes at baseline after implant placement, and 12 months follow up visits. These images are the only way to provide 3 dimensional view of bone around implants (Mesial-Distal, Buccal-Lingual). Marginal bone level changes will be recorded on the mid-mesial, mid-distal, mid-labial, and mid-lingual sites for each implant from the reference line (RL) of the implant platform immediately after implant placement and 12 months follow up visits. All measurements will be made utilizing a coDiagnostiX software used at University of Kentucky College of Dentistry. Marginal bone changes around implants for each site (i.e., Mesial, Distal, Buccal, and Lingual) will be digitally analyzed using the software and statistically analyzed and compared between groups utilizing SPSS software.
Osstell Value Assessment
Time frame: 12 months
Osstell® RFA (Resonance Frequency Analysis) values will be recorded immediately after implant placement, 3 months, and 12 months follow up visits to report implant stability during the healing time. RFA values for each implant will be statistically analyzed and compared between and within groups utilizing SPSS software.
3D Printed Models Assessment
Time frame: 12 months
3D printed models will be generated from intraoral scan prior to baseline extraction visit and 3, 12 months follow up. Volumetric changes will be measured and analyzed digitally with compare software.
Photographic Documentation
Time frame: 12 months
Photographic documentation will be made using a digital camera for each visit to clinically evaluate the peri-implant tissue healing response around implants with immediate vs. early placements.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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.
Ahmad KutKut, DDS, MS principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm) and Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm) in people with Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets, run by Ahmad Kutkut at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 May 2023. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Examination: Implant Success and Failure Criteria (time frame: 12 months). The study lists 5 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 30 May 2023.