Intra-bony PocketsPhase 1NCT04824898
The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry
A Phase 1 study testing Simvastatin and injectable plasma rich fibrin in people with Intra-bony Pockets, run by Ain Shams University at 1 site in Egypt.
Trial summary
Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL)… Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Intra-bony Pockets
- What is being tested?
- Simvastatin and injectable plasma rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 20 Sep 2022
- Phase
- Phase 1
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Age range between 25 and 40 years
- Patients with severe chronic periodontitis having probing depth (PD) ≥6 mm and clinical attachment loss (CAL) ≥5 mm , or Stage III periodontitis
- Patient having vertical bone loss ≥3 mm (distance between alveolar crest and base of the defect as confirmed by preoperative intraoral periapical radiographs using standardized parallel technique.)
- Good compliance with the plaque control instructions following initial therapy
- Availability for follow up and maintenance program.
Who cannot join
- • Patient with any systemic disease or conditions
- Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of trial and during the study.
- Patients who have undergone any periodontal treatment in the last 6 months
- Pregnant and Lactating.
- Reported allergy to any type of statins
- Subjects who were tobacco or alcohol users
- Vulnerable group of patients (e.g.: prisoners , handicapped , or decisionally impaired individuals )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Injectable Plasma Rich Fibrin (I-PRF) Versus Simvastatin Gel in Surgical Management of Infra-bony Defects (A Randomized Controlled Clinical Trial)
Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level.
and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called "blood concentrate ". So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,
Read the detailed description
Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
- Oral hygiene instructions will be given to all patients.
- Full mouth Scaling and root planing (SRP) will be performed under local anesthesia.
- 4 to 8 weeks after the non-surgical periodontal therapy patients will be reassessed clinically and radiographically For all patients who are suitable for the study the following clinical and radiographic evaluation parameters will be measured: (All parameters will be recorded Pre-operatively (base line) and 6 months Post operatively by an examiner who will be masked to the type of treatment received by the individuals).
- Conditions
- Intra-bony Pockets
- Being tested
- Simvastatin, injectable plasma rich fibrin
- Keywords
- intra-bony pocket, I-prf, infra-bony pocket defect, vertical bone loss treatment, simvastation in pockets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation
injectable plasma rich fibrinOther
Also called i-prf
I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection
| Study group | Role | What they receive |
|---|---|---|
| simvastatin 1.2%gel | Experimental | simvastatin 1.2%gel applied after open flap debridment in group I Receives: Drug: Simvastatin |
| I-prf | Experimental | Injectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment Receives: Other: injectable plasma rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI)
clinical score
Measured: change from basline at 6 months
Gingival index (GI)
clinical score
Measured: change from basline at 6 months
Probing depth (PD)
clinical score
Measured: change from basline at 6 months
Clinical attachment level (CAL)
clinical score
Measured: change from basline at 6 months
Secondary outcomes (1)
radiographIc
assess the alveolar bone level radiographically
Measured: from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 Jan 2021
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-bony PocketsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- suzan seif allah, professor, Study director, faculty of dentistry ainshams universityola m ezzat, ass professor, Study chair, faculty of dentistry ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824898
- Sponsor's protocol ID
- OMD-2019-1
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Injectable Plasma Rich Fibrin (I-PRF) Versus Simvastatin Gel in Surgical Management of Infra-bony Defects (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04824898
- Acronym / sponsor ID
- OMD-2019-1
- Conditions
- Intra-bony Pockets
- Keywords
- intra-bony pocket, I-prf, infra-bony pocket defect, vertical bone loss treatment, simvastation in pockets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 1 Apr 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.
Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level.
and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called "blood concentrate ". So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,
Detailed description
Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
- Oral hygiene instructions will be given to all patients.
- Full mouth Scaling and root planing (SRP) will be performed under local anesthesia.
- 4 to 8 weeks after the non-surgical periodontal therapy patients will be reassessed clinically and radiographically For all patients who are suitable for the study the following clinical and radiographic evaluation parameters will be measured: (All parameters will be recorded Pre-operatively (base line) and 6 months Post operatively by an examiner who will be masked to the type of treatment received by the individuals).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin 1.2%gel | Experimental | Drug: Simvastatinsimvastatin 1.2%gel applied after open flap debridment in group I |
| I-prf | Experimental | Other: injectable plasma rich fibrinInjectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age range between 25 and 40 years
Key exclusion criteria (7 listed)
- • Patient with any systemic disease or conditions
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 |
|---|---|---|
| SimvastatinStatins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation | Drug | simvastatin 1.2%gel |
| injectable plasma rich fibrinAlso: i-prfI- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection | Other | I-prf |
Primary outcome
Plaque index (PI)
Time frame: change from basline at 6 months
clinical score
Gingival index (GI)
Time frame: change from basline at 6 months
clinical score
Probing depth (PD)
Time frame: change from basline at 6 months
clinical score
Clinical attachment level (CAL)
Time frame: change from basline at 6 months
clinical score
1 secondary outcome
radiographIc
Time frame: from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Yes
Related trials for Intra-bony Pockets
Recruiting
Biologicals in Management of Intra-Bony Defects
Intra-bony Pockets, Periodontitis
Enrolling by invitation
Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)
Periodontal Bone Loss, Periodontitis Stage III
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.
suzan seif allah, professor study director
faculty of dentistry ainshams university
ola m ezzat, ass professor study chair
faculty of dentistry ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin and injectable plasma rich fibrin in people with Intra-bony Pockets, run by Ain Shams 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 5 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 1 Apr 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Plaque index (PI) (time frame: change from basline at 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 1 Apr 2021.