Wound Healing DisorderBBLISNCT06371430
Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery
A study testing Dental Implant insertion and tooth extraction in people with Wound Healing Disorder and Wounds and Injuries, run by Biointelligent Technology Systems SL at 1 site in Spain.
Trial summary
The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing Disorder, Wounds and Injuries, Wound Surgical
- What is being tested?
- Dental Implant insertion and tooth extraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 14 Apr 2021to 14 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- sufficient residual bone volume to accommodate implant placement without requiring bone augmentation, minimum ridge height and width of ≥ 9mm and ≥ 6mm, respectively, and healed bone sites with a minimum of 1 months of post-extraction healing.
Who cannot join
- Patients with alcoholism.
- Smoking habits.
- History of illicit drug use were excluded.
- Patients with heart diseases.
- Diabetes.
- Previous bone regenerative or augmentation procedures.
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- Bleeding disorders.
- Compromised immune systems.
- History of radiation therapy
- Treatment with steroids or bisphosphonates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Clinical Human Trial , Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling
The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.
Read the detailed description
Ensuring implant stability and longevity is pivotal for patient satisfaction and quality of life. Our recent discovery, BBL, novel bone bioactive liquid, demonstrated promising properties in improving implant surfaces, alleviating pain, and expediting oral healing. In this multi-center randomized, double-blind clinical trial, investigators sought to evaluate the impact of BBL on the clinical performance of Galaxy TS implants.
Methods Investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.
- Conditions
- Wound Healing Disorder, Wounds and Injuries, Wound Surgical
- Being tested
- Dental Implant insertion and tooth extraction
- Keywords
- Bone bioactive liquid, Dental implant, Oral wound healing
- Medical subject headings
- Wounds and Injuries, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant insertion and tooth extractionDevice
The osteotomies were carried out at a speed of 800 rpm, using sequential burs of similar diameter for both the maxilar and the mandibular side. The drilling protocols followed the recommendations provided by the manufacturer, the Galaxy-Ziacom implant system, for standard drilling.
The insertion of the implants was initiated using a motor handpiece at a speed of 20-50 rpm, without irrigation. The installation process was completed using a manual surgical torque wrench indicator. The maximum torque value (Ncm) reached at the end of implant insertion was recorded as the insertion torque (IT). A total of 264 implants were inserted in 33 patients, 160 implants were post-extraction and 104 implants were inserted after at least one-month post-extraction. The sutures were typically removed 1 week after the surgery, during the postoperative follow-up appointment.
| Study group | Role | What they receive |
|---|---|---|
| Pain Scale | Placebo comparator | To assess the efficacy of the surgical procedure, pain scale evaluations were conducted on day 1,4 and 7, following the surgery. This evaluation involved a direct contact with the patients to gauge their subjective pain experience. A modified visual analog scale (VAS) was utilized, as described in reference [34]. No pain scale = 0, moderate pain scale = 5 and maximum pain scale = 10 [21]. In addition to efficacy measurements, safety measurements were also considered. The occurrence of adverse events (AEs) and serious adverse events (SAEs) was monitored throughout the duration of the study. These events were either detected by the investigator or reported by the patients themselves. The aim was to identify any potential complications or issues that arose because of the surgical procedure. Receives: Device: Dental Implant insertion and tooth extraction |
| RFA and ISQ measurements | Placebo comparator | After the implants were fully seated, a Smartpeg specific to the implant system and restorative platform diameter was used for each implant. RFA was then performed using an OsstellMentor device from Ostell/Integration Diagnostics in Gothenburg, Sweden. This analysis was used to measure the ISQ values for all implant surfaces at days 0, 7 and 30 post-surgeries. For each implant, 4 readings were taken per lingual, mesial, distal, and vestibular direction. The average ISQ values of all the readings were recorded. Following the RFA measurements, new sterile healing abutments were inserted, and the incisions were sutured to close the wounds. Receives: Device: Dental Implant insertion and tooth extraction |
| CBCT analysis | Experimental | CBCTs were captured for implants from six patients with total of 24 implants, with 12 implants Galaxy TS (non-treated) on one side of the jaw and 12 implants Galaxy TSA (treated with BBL) on the other side of the jaw. All patients in this group had implants inserted in the upper jaw and each patient had 4 implants inserted (All on 4 technique). The CBCTs scans were conducted at days 1 and 60 post-surgeries using a 3D Accuitomo 170 scanner (J. MORITA EUROPE GMBH). The scans were performed with the following technical parameters: 90 kV, 5 mA, 87.5 mAs, voxel size ranging from 125-250 µm, 360° rotation, and scanning time of 17.5 s as previously described [32]. To ensure accuracy, a bite mark was utilized during CBCT scanning to correspond to the patients' midline. Consistency in bite mark placement was maintained to ensure that the same slice was obtained for each scan performed on the patient Receives: Device: Dental Implant insertion and tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISQ measurements
Implant stapelity
Measured: 3 month
Secondary outcomes (1)
CBCTs analysis
Quantify new bon formation
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start14 Apr 2021
- Primary completion14 Jun 2022
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Pública de Navarra, Dasman Diabetes Institute
- Responsible party
- Principal investigator, Maher Atari Abouasi, Biointelligent Technology Systems SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371430
- Sponsor's protocol ID
- Biointelligent Technology Syst
- Acronym
- BBLIS
- Status last verified
- Jun 2024
- First submitted
- 9 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Clinical Human Trial , Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling
- ClinicalTrials.gov ID
- NCT06371430
- Acronym / sponsor ID
- BBLIS / Biointelligent Technology Syst
- Conditions
- Wound Healing Disorder, Wounds and Injuries, Wound Surgical
- Keywords
- Bone bioactive liquid, Dental implant, Oral wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Pública de Navarra, Dasman Diabetes Institute
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 17 Apr 2024 (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 investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.
Detailed description
Ensuring implant stability and longevity is pivotal for patient satisfaction and quality of life. Our recent discovery, BBL, novel bone bioactive liquid, demonstrated promising properties in improving implant surfaces, alleviating pain, and expediting oral healing. In this multi-center randomized, double-blind clinical trial, investigators sought to evaluate the impact of BBL on the clinical performance of Galaxy TS implants.
Methods Investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Scale | Placebo comparator | Device: Dental Implant insertion and tooth extractionTo assess the efficacy of the surgical procedure, pain scale evaluations were conducted on day 1,4 and 7, following the surgery. This evaluation involved a direct contact with the patients to gauge their subjective pain experience. A modified visual analog scale (VAS) was utilized, as described in reference [34]. No pain scale = 0, moderate pain scale = 5 and maximum pain scale = 10 [21]. In addition to efficacy measurements, safety measurements were also considered. The occurrence of adverse events (AEs) and serious adverse events (SAEs) was monitored throughout the duration of the study. These events were either detected by the investigator or reported by the patients themselves. The aim was to identify any potential complications or issues that arose because of the surgical procedure. |
| RFA and ISQ measurements | Placebo comparator | Device: Dental Implant insertion and tooth extractionAfter the implants were fully seated, a Smartpeg specific to the implant system and restorative platform diameter was used for each implant. RFA was then performed using an OsstellMentor device from Ostell/Integration Diagnostics in Gothenburg, Sweden. This analysis was used to measure the ISQ values for all implant surfaces at days 0, 7 and 30 post-surgeries. For each implant, 4 readings were taken per lingual, mesial, distal, and vestibular direction. The average ISQ values of all the readings were recorded. Following the RFA measurements, new sterile healing abutments were inserted, and the incisions were sutured to close the wounds. |
| CBCT analysis | Experimental | Device: Dental Implant insertion and tooth extractionCBCTs were captured for implants from six patients with total of 24 implants, with 12 implants Galaxy TS (non-treated) on one side of the jaw and 12 implants Galaxy TSA (treated with BBL) on the other side of the jaw. All patients in this group had implants inserted in the upper jaw and each patient had 4 implants inserted (All on 4 technique). The CBCTs scans were conducted at days 1 and 60 post-surgeries using a 3D Accuitomo 170 scanner (J. MORITA EUROPE GMBH). The scans were performed with the following technical parameters: 90 kV, 5 mA, 87.5 mAs, voxel size ranging from 125-250 µm, 360° rotation, and scanning time of 17.5 s as previously described [32]. To ensure accuracy, a bite mark was utilized during CBCT scanning to correspond to the patients' midline. Consistency in bite mark placement was maintained to ensure that the same slice was obtained for each scan performed on the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older.
- sufficient residual bone volume to accommodate implant placement without requiring bone augmentation, minimum ridge height and width of ≥ 9mm and ≥ 6mm, respectively, and healed bone sites with a minimum of 1 months of post-extraction healing.
Key exclusion criteria (10 listed)
- Patients with alcoholism.
- Smoking habits.
- History of illicit drug use were excluded.
- Patients with heart diseases.
- Diabetes.
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 |
|---|---|---|
| Dental Implant insertion and tooth extractionThe osteotomies were carried out at a speed of 800 rpm, using sequential burs of similar diameter for both the maxilar and the mandibular side. The drilling protocols followed the recommendations provided by the manufacturer, the Galaxy-Ziacom implant system, for standard drilling. The insertion of the implants was initiated using a motor handpiece at a speed of 20-50 rpm, without irrigation. The installation process was completed using a manual surgical torque wrench indicator. The maximum torque value (Ncm) reached at the end of implant insertion was recorded as the insertion torque (IT). A total of 264 implants were inserted in 33 patients, 160 implants were post-extraction and 104 implants were inserted after at least one-month post-extraction. The sutures were typically removed 1 week after the surgery, during the postoperative follow-up appointment. | Device | CBCT analysis, Pain Scale, RFA and ISQ measurements |
Primary outcome
ISQ measurements
Time frame: 3 month
Implant stapelity
1 secondary outcome
CBCTs analysis
Time frame: 2 month
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 4 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant insertion and tooth extraction in people with Wound Healing Disorder and Wounds and Injuries, run by Biointelligent Technology Systems SL 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 2 inclusion and 10 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 4 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
ISQ measurements (time frame: 3 month). 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 4 Jun 2024.