Bone LossPhase 4GaliboneNCT06338241
Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model
A Phase 4 study testing Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin and Bovine Hydroxyapatite in people with Bone Loss and Regenerative Inflammation, run by Mario Pérez Sayáns at 2 sites in Spain.
Trial summary
The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Regenerative Inflammation
- What is being tested?
- Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin and Bovine Hydroxyapatite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Mar 2024to 2 Sep 2025
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be of legal age.
- Participants must provide informed consent for participation in the study.
- Participants must require extraction of both impacted mandibular third molars.
- Both impacted molars must exhibit a similar level of complexity for extraction.
- Participants must have no history of infection in the impacted molars prior to extraction.
- Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).
Who cannot join
- Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
- Participants currently receiving medications contraindicated for dental extractions.
- Participants under the age of legal consent.
- Participants who have undergone head and neck radiotherapy within the past 18 months.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry University of Murcia
Murcia
FABIO CAMACHO ALONSO, PHD, fcamacho@um.es
- Recruiting
Faculty of Dentistry of Universidade de Santiago de Compostela
Santiago de Compostela, A Coruña, 15705
MARIO PEREZ SAYANS GARCIA, PHD, PHD, mario.perez@usc.es
About this study
Official title: Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars
The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.
Read the detailed description
With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.
- Conditions
- Bone Loss, Regenerative Inflammation
- Being tested
- Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin, Bovine Hydroxyapatite
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatinCombination product
Also called Galibone
The intervention description for Galibone+ in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. Galibone is indicated to treat segmental and cavity bone loss, aesthetic repairs and bone augmentations (such as inlay or onlay grafts); to fill dental alveolar bone; for the placement of dental implants; for the stabilization of osteotomies and prostheses in dentistry.
Bovine HydroxyapatiteOther
Also called Bio-Oss
The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.
| Study group | Role | What they receive |
|---|---|---|
| Galibone Group | Experimental | The Galibone+ experimental group includes participants receiving Galibone+ after impacted mandibular third molar extraction, testing its osteogenic properties. Galibone+ is prepared per manufacturer's instructions, potentially by immersing in sterile saline. Applied post-extraction into the socket using specialized instruments, it's compared to a control group receiving Bio-Oss, a standard xenograft material. Experimental group patients receive postoperative medications, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Goal: Assess Galibone+'s efficacy in bone regeneration versus control. Receives: Combination Product: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin |
| Control group | Active comparator | The control group serves as an active comparator to the Galibone+ experimental group in this study. Participants undergo identical impacted mandibular third molar extraction procedures as the experimental group but receive a standard material, likely Bio-Oss, instead of Galibone+.
Bio-Oss, a widely used xenograft material in dental surgeries, acts as a benchmark due to its osteoconductive properties. Applied post-extraction into the socket with specialized instruments, it provides a reference for comparing Galibone+'s efficacy. Patients in the control group receive postoperative medications as per the study protocol, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Receives: Other: Bovine Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Regeneration_Reduction in radiolucent volume
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction.
Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)).
High values mean more radiopacity and better regeneration.
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_bone volume
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction.
Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration.
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_bone density
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction.
Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_Fractal dimension
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction.
Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface).
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Secondary outcomes (5)
Pain levels through visual analog scale
Assessment of pain experienced by participants using a visual analog scale (VAS) at various time points post-extraction. It comprehends values between 0-10, where 10 is the worst situation.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Clinical Inflammation evaluating by presence/absence
Evaluation of postoperative inflammation around the extraction site using clinical examination and assessment tools (presence/absence).
The presence of inflammation means the worst prognosis.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Healing measured by healing index
The healing progress will be assessed using the Healing Index (HI) developed by Hamzani \& Chaushu (2018) and Landry (1988). The HI score ranges from 0 to 5, where 0 indicates poor healing and 5 indicates excellent healing.
To ensure consistency and reliability in the assessment of healing, two independent researchers will evaluate the healing progress for all participants. The level of agreement between the researchers will be assessed using Cohen's Kappa index (Mandrekar, 2011). A Cohen's Kappa index value of 0.91 was achieved for the assessment of inflammation level, indicating a high degree of agreement. Similarly, agreement levels exceeding 0.90 were obtained across all HI levels, demonstrating a high level of concordance in the assessment of healing progress.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Post-surgical complications evaluated by presence or absense
Monitoring and recording of any complications following the extraction procedure, such as alveolitis, trismus, infection, and hematoma (presence/absence).
The presence of complications is related to a worse prognosis.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Oral Health-related Quality of Life measured by OHIP-14 test
Assessment of the impact of treatment on patients' quality of life using validated instruments (OHIP-14).
Lower scores: They indicate that the person experiences less impact of oral health problems on their quality of life. That is, they have fewer problems or feel less the impact of these problems in their daily lives.
Intermediate scores: Suggest a moderate impact of oral health problems on quality of life. The person may experience some difficulties or discomfort related to their oral health, but they do not necessarily significantly affect their daily functioning.
Higher scores: Indicate a significant impact of oral health problems on quality of life. The person may experience a wide range of problems that affect their general well-being, including pain, eating difficulties, sleep problems, etc.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start2 Mar 2024
- Primary completion2 Jun 2025 (estimated)
- Study completion2 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Pérez Sayáns
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia
- Responsible party
- Sponsor-investigator, Mario Pérez Sayáns, University of Santiago de Compostela
- Investigators
- Abel García García, PhD, MD, Study director, Universidade de Santaiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338241
- Sponsor's protocol ID
- CPP2021-008391
- Acronym
- Galibone
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT06338241
- Acronym / sponsor ID
- Galibone / CPP2021-008391
- Conditions
- Bone Loss, Regenerative Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mario Pérez SayánsUniversity, hospital or other
- Collaborators
- Universidad de Murcia
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 29 Mar 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 clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.
Detailed description
With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galibone Group | Experimental | Combination Product: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatinThe Galibone+ experimental group includes participants receiving Galibone+ after impacted mandibular third molar extraction, testing its osteogenic properties. Galibone+ is prepared per manufacturer's instructions, potentially by immersing in sterile saline. Applied post-extraction into the socket using specialized instruments, it's compared to a control group receiving Bio-Oss, a standard xenograft material. Experimental group patients receive postoperative medications, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Goal: Assess Galibone+'s efficacy in bone regeneration versus control. |
| Control group | Active comparator | Other: Bovine HydroxyapatiteThe control group serves as an active comparator to the Galibone+ experimental group in this study. Participants undergo identical impacted mandibular third molar extraction procedures as the experimental group but receive a standard material, likely Bio-Oss, instead of Galibone+. Bio-Oss, a widely used xenograft material in dental surgeries, acts as a benchmark due to its osteoconductive properties. Applied post-extraction into the socket with specialized instruments, it provides a reference for comparing Galibone+'s efficacy. Patients in the control group receive postoperative medications as per the study protocol, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be of legal age.
- Participants must provide informed consent for participation in the study.
- Participants must require extraction of both impacted mandibular third molars.
- Both impacted molars must exhibit a similar level of complexity for extraction.
- Participants must have no history of infection in the impacted molars prior to extraction.
Key exclusion criteria (4 listed)
- Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
- Participants currently receiving medications contraindicated for dental extractions.
- Participants under the age of legal consent.
- Participants who have undergone head and neck radiotherapy within the past 18 months.
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 |
|---|---|---|
| Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatinAlso: GaliboneThe intervention description for Galibone+ in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. Galibone is indicated to treat segmental and cavity bone loss, aesthetic repairs and bone augmentations (such as inlay or onlay grafts); to fill dental alveolar bone; for the placement of dental implants; for the stabilization of osteotomies and prostheses in dentistry. | Combination product | Galibone Group |
| Bovine HydroxyapatiteAlso: Bio-OssThe intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties. | Other | Control group |
Primary outcome
Bone Regeneration_Reduction in radiolucent volume
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration.
Bone Regeneration_bone volume
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration.
Bone Regeneration_bone density
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.
Bone Regeneration_Fractal dimension
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface).
5 secondary outcomes
Pain levels through visual analog scale
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Clinical Inflammation evaluating by presence/absence
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Healing measured by healing index
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Post-surgical complications evaluated by presence or absense
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Oral Health-related Quality of Life measured by OHIP-14 test
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Abel García García, PhD, MD study director
Universidade de Santaiago de Compostela
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin and Bovine Hydroxyapatite in people with Bone Loss and Regenerative Inflammation, run by Mario Pérez Sayáns at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact MARIO PEREZ SAYANS GARCIA, PHD, PHD (+34626233504, mario.perez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Regeneration_Reduction in radiolucent volume (time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months). The study lists 4 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 3 Apr 2024.