SimvastatinNCT05031923
Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy
A study testing SMV and antimicrobial photodynamic therapy and SMV application in people with Simvastatin and Photodynamic Therapy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Simvastatin, Photodynamic Therapy, Periodontal Diseases
- What is being tested?
- SMV and antimicrobial photodynamic therapy and SMV application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2021to Aug 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients were all healthy and free from any systemic disease;
- no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
- patients were willing and able to return for multiple follow-up visits;
- good levels of oral hygiene
Who cannot join
- Pregnant and lactating female patients,
- smokers,
- alcoholics,
- those receiving any medication that could affect healing of soft or hard tissue
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511
Dalia R Issa, PhD, 01007753636 ext. 002, dalia_rasheed@hotmail.com
About this study
Official title: Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.
- Conditions
- Simvastatin, Photodynamic Therapy, Periodontal Diseases
- Being tested
- SMV and antimicrobial photodynamic therapy, SMV application
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMV and antimicrobial photodynamic therapyProcedure or surgery
Application of SMV and antimicrobial photodynamic therapy in intrabony defects
SMV applicationProcedure or surgery
Application of SMV without antimicrobial photodynamic therapy in intrabony defects
| Study group | Role | What they receive |
|---|---|---|
| SMV and antimicrobial photodynamic therapy | Experimental | Application SMV and antimicrobial photodynamic therapy in intrabony defect Receives: Procedure: SMV and antimicrobial photodynamic therapy |
| SMV application | Active comparator | Application SMV in intrabony defect Receives: Procedure: SMV application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation and measurements of the defect in millimeters
Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Measured: 9 months
Radiographic evaluation and measurements of the defect in millimeters
Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start16 Oct 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimvastatinStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031923
- Sponsor's protocol ID
- waiting..
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05031923
- Acronym / sponsor ID
- waiting..
- Conditions
- Simvastatin, Photodynamic Therapy, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 2 Sep 2021 (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.
Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMV and antimicrobial photodynamic therapy | Experimental | Procedure: SMV and antimicrobial photodynamic therapyApplication SMV and antimicrobial photodynamic therapy in intrabony defect |
| SMV application | Active comparator | Procedure: SMV applicationApplication SMV in intrabony defect |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients were all healthy and free from any systemic disease;
- no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
- patients were willing and able to return for multiple follow-up visits;
- good levels of oral hygiene
Key exclusion criteria (4 listed)
- Pregnant and lactating female patients,
- smokers,
- alcoholics,
- those receiving any medication that could affect healing of soft or hard tissue
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 |
|---|---|---|
| SMV and antimicrobial photodynamic therapyApplication of SMV and antimicrobial photodynamic therapy in intrabony defects | Procedure or surgery | SMV and antimicrobial photodynamic therapy |
| SMV applicationApplication of SMV without antimicrobial photodynamic therapy in intrabony defects | Procedure or surgery | SMV application |
Primary outcome
Clinical evaluation and measurements of the defect in millimeters
Time frame: 9 months
Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Radiographic evaluation and measurements of the defect in millimeters
Time frame: 9 months
Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh 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 SMV and antimicrobial photodynamic therapy and SMV application in people with Simvastatin and Photodynamic Therapy, run by Kafrelsheikh 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 4 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 11 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 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 Dalia R Issa, PhD (01007753636 ext. 002, dalia_rasheed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation and measurements of the defect in millimeters (time frame: 9 months). The study lists 2 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 11 Apr 2024.