InfectionNCT06382974
Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP
A study testing Cyst enucleation and bone grafting in people with Infection and Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Cyst enucleation and bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2024to Mar 2026
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female patients
- Patients 18 to 40 years old
- Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;
- Focal teeth were preserved with root canal treatment;
- No previous surgical treatment of the cyst site;
- No evidence of acute inflammation;
- In good physical status and oral health;
- Regular attendance at control visits
Who cannot join
- Patients < 17 years old
- Radicular cyst with a maximum diameter < 1.5 cm.
- Pregnancy or lactation
- Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;
- Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;
- Patients with uncontrolled periodontal conditions, endodontic conditions, and other oral disorders;
- Heavy smokers (10 cigarettes/day or more)
Trial locations and contacts
1 site in 1 country.
Mohamed Mosa contact
About this study
Official title: Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP in the Treatment of Bone Defects After Radicular Jaw Cyst Enucleation Using CBCT-based Volumetric Analysis
This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects.
Read the detailed description
Statement of the problem:
According to the literature, the residual bone defects after medium-large-sized jaw cyst enucleation pose the risk for infection, insufficient healing, and pathological fracture. the gold standard of bone grafting materials remains the autologous bone graft, yet it is accompanied by risks including second surgery, the morbidity of the donor site, excessive bleeding, etc.
Therefore, there is a constant search for alternative bone grafting materials, this is where the addition of atorvastatin to an osteoconductive synthetic bone grafting material (β-TCP) comes in. β-TCP takes anywhere from 6 to 18 months for complete resorption and replacement by bone, according to the literature.
The addition of an osteoinductive material to an osteoconductive grafting material like β-TCP holds two premises; increasing the resorption of the β-TCP particles at the expense of bone deposition, and therefore leads to hastening the bone generation of the residual bone defects.
Rationale:
Studies have shown that the local application of lipid-lowering drugs, statins, induces bone growth by stimulating BMP-2. therefore, the addition of these pharmacological agents to osteoconductive bone graft materials, which lack osteogenic properties, could be a promising approach for bone regeneration.
However, there is still no consensus in the literature on the optimal therapeutic dose and mode of application for statins. Furthermore, limited studies are available in the literature regarding the use of statins especially Atorvastatin as a biological modifier in filling bone defects after cyst enucleation.
Therefore, the purpose of this study is to validate and evaluate the osteoinductivity of statins+ β-TCP combination using the Gouda et al., methodology used in maxillary sinus lifting using simvastatin but instead using atorvastatin in filling the residual defects of medium-large odontogenic radicular cysts (1.5 - 4 cm), which shows the suppressive influence on bone formation, as well as a greater risk for pathological fracture, infection, and insufficient bone healing.
Methodology:
The ratio of atorvastatin to β-TCP will be 0.1 mg: 14 mg, which was the methodology adopted by Gouda et al, based on the methodology of Nyan et al.
- Being tested
- Cyst enucleation and bone grafting
- Keywords
- bone regeneration, bone graft, volumetric analysis
- Medical subject headings
- Infections, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyst enucleation and bone graftingProcedure or surgery
Also called Bone grafting
cyst enucleation followed by bone grafting the residual bone defects using Atorvastatin combined with β-TCP.
| Study group | Role | What they receive |
|---|---|---|
| bone grafting using atorvastatin combined with beta-TCP | Experimental | the 10 volunteers will undergo cyst enucleation followed by filling the residual bone defects with atorvastatin combined with beta-TCP in the ratio of 0.1 mg: 14 mg. Receives: Procedure: Cyst enucleation and bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of shrinkage of the residual bone defect
the shrinkage of the residual bone defects after bone grafting, measured from the following formula: pre-operative cyst volume - 3/6 months post-operative defect volume/pre-operative cyst volume x 100%.
it will be measured radiographically using CBCT through manual segmentation
Measured: 3 moths post-operatively and 6 months post-operatively
Secondary outcomes (1)
Incidence of Inflammation at the grafted site
any signs of inflammation; edema, redness or discharge
Measured: 1 week post-operatively, 3 months post-operatively and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A case series study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Gamal Mohamed Mahmoud, Cairo University
- Investigators
- Salah Yassin, Study director, department of oral and maxillofacial surgery, cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382974
- Sponsor's protocol ID
- 3-3-14
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2024
- Last updated
- 13 Aug 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP in the Treatment of Bone Defects After Radicular Jaw Cyst Enucleation Using CBCT-based Volumetric Analysis
- ClinicalTrials.gov ID
- NCT06382974
- Acronym / sponsor ID
- 3-3-14
- Keywords
- bone regeneration, bone graft, volumetric analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 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.
This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects.
Detailed description
Statement of the problem:
According to the literature, the residual bone defects after medium-large-sized jaw cyst enucleation pose the risk for infection, insufficient healing, and pathological fracture. the gold standard of bone grafting materials remains the autologous bone graft, yet it is accompanied by risks including second surgery, the morbidity of the donor site, excessive bleeding, etc.
Therefore, there is a constant search for alternative bone grafting materials, this is where the addition of atorvastatin to an osteoconductive synthetic bone grafting material (β-TCP) comes in. β-TCP takes anywhere from 6 to 18 months for complete resorption and replacement by bone, according to the literature.
The addition of an osteoinductive material to an osteoconductive grafting material like β-TCP holds two premises; increasing the resorption of the β-TCP particles at the expense of bone deposition, and therefore leads to hastening the bone generation of the residual bone defects.
Rationale:
Studies have shown that the local application of lipid-lowering drugs, statins, induces bone growth by stimulating BMP-2. therefore, the addition of these pharmacological agents to osteoconductive bone graft materials, which lack osteogenic properties, could be a promising approach for bone regeneration.
However, there is still no consensus in the literature on the optimal therapeutic dose and mode of application for statins. Furthermore, limited studies are available in the literature regarding the use of statins especially Atorvastatin as a biological modifier in filling bone defects after cyst enucleation.
Therefore, the purpose of this study is to validate and evaluate the osteoinductivity of statins+ β-TCP combination using the Gouda et al., methodology used in maxillary sinus lifting using simvastatin but instead using atorvastatin in filling the residual defects of medium-large odontogenic radicular cysts (1.5 - 4 cm), which shows the suppressive influence on bone formation, as well as a greater risk for pathological fracture, infection, and insufficient bone healing.
Methodology:
The ratio of atorvastatin to β-TCP will be 0.1 mg: 14 mg, which was the methodology adopted by Gouda et al, based on the methodology of Nyan et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A case series study.
| Arm | Type | Receives |
|---|---|---|
| bone grafting using atorvastatin combined with beta-TCP | Experimental | Procedure: Cyst enucleation and bone graftingthe 10 volunteers will undergo cyst enucleation followed by filling the residual bone defects with atorvastatin combined with beta-TCP in the ratio of 0.1 mg: 14 mg. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female patients
- Patients 18 to 40 years old
- Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;
- Focal teeth were preserved with root canal treatment;
- No previous surgical treatment of the cyst site;
Key exclusion criteria (7 listed)
- Patients < 17 years old
- Radicular cyst with a maximum diameter < 1.5 cm.
- Pregnancy or lactation
- Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;
- Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;
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 |
|---|---|---|
| Cyst enucleation and bone graftingAlso: Bone graftingcyst enucleation followed by bone grafting the residual bone defects using Atorvastatin combined with β-TCP. | Procedure or surgery | bone grafting using atorvastatin combined with beta-TCP |
Primary outcome
The Rate of shrinkage of the residual bone defect
Time frame: 3 moths post-operatively and 6 months post-operatively
the shrinkage of the residual bone defects after bone grafting, measured from the following formula: pre-operative cyst volume - 3/6 months post-operative defect volume/pre-operative cyst volume x 100%. it will be measured radiographically using CBCT through manual segmentation
1 secondary outcome
Incidence of Inflammation at the grafted site
Time frame: 1 week post-operatively, 3 months post-operatively and 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- first in-vivo study to test the methodology adopted in this researchLink provided by the sponsor.
- the clinical study methodology adopted in this researchLink provided by the sponsor.
- 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.
Mohamed Mosa contact
Salah Yassin study director
department of oral and maxillofacial surgery, cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyst enucleation and bone grafting in people with Infection and Bone Loss, run by Cairo University at 1 site in Egypt.
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 7 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 13 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara Mahmoud (01100764737, yara.mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of shrinkage of the residual bone defect (time frame: 3 moths post-operatively and 6 months post-operatively). 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 13 Aug 2024.