Socket PreservationPhase 4NCT03228771
Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)
A Phase 4 study testing PRGF/ATV and ATV gel in people with Socket Preservation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- PRGF/ATV and ATV gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to 15 Aug 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- Both sexes.
- Age from 20 - 50 years old.
- Having at least one hopeless tooth indicated for extraction.
- Patient should agree to sign a written consent after the nature of the study will be explained.
Who cannot join
- Smokers.
- Pregnant and breast feeding females.
- Prisoners and handicapped patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.
Read the detailed description
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation.
Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich in growth factors which might be essential to proper tissue repair and wound healing. PRGF acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they do not exert any effects on the stem cells present in bone tissue, whose differentiation is regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a safe and cost effective alternative to this problem and can affect bone regeneration. Statins are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the osteoblasts from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.
- Conditions
- Socket Preservation
- Being tested
- PRGF/ATV, ATV gel
- Keywords
- PRGF, Statins, socket augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF/ATVDrug
Also called platelets rich in growth factors
Atorvastatin loaded in PRGF fibrin scaffold
ATV gelDrug
Also called Atorvastatin gel
Atorvastatin loaded in methyl cellulose gel
| Study group | Role | What they receive |
|---|---|---|
| PRGF/ATV | Active comparator | Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF). Receives: Drug: PRGF/ATV |
| ATV gel | Active comparator | Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. Receives: Drug: ATV gel |
| Empty socket | No intervention | Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical measurements Ridge width
Ridge width
Measured: 1 year
Secondary outcomes (1)
clinical measurements ridge height
Ridge height
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startMar 2016
- Primary completionJun 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies 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
- Model description
- 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Nasr, Ain Shams University
- Investigators
- Khaled A Ghaffar, Professor, Study director, Ain Shams UniversityOla M Ezzatt, Lecturer, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228771
- Sponsor's protocol ID
- FDASU-RECM041515
- Status last verified
- Sep 2018
- First submitted
- 26 May 2015
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)
- ClinicalTrials.gov ID
- NCT03228771
- Acronym / sponsor ID
- FDASU-RECM041515
- Conditions
- Socket Preservation
- Keywords
- PRGF, Statins, socket augmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 25 Jul 2017 (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.
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.
Detailed description
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation.
Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich in growth factors which might be essential to proper tissue repair and wound healing. PRGF acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they do not exert any effects on the stem cells present in bone tissue, whose differentiation is regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a safe and cost effective alternative to this problem and can affect bone regeneration. Statins are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the osteoblasts from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
| Arm | Type | Receives |
|---|---|---|
| PRGF/ATV | Active comparator | Drug: PRGF/ATVGroup I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF). |
| ATV gel | Active comparator | Drug: ATV gelGroup II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. |
| Empty socket | No intervention | –Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
- Both sexes.
- Age from 20 - 50 years old.
- Having at least one hopeless tooth indicated for extraction.
- Patient should agree to sign a written consent after the nature of the study will be explained.
Key exclusion criteria (3 listed)
- Smokers.
- Pregnant and breast feeding females.
- Prisoners and handicapped patients.
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 |
|---|---|---|
| PRGF/ATVAlso: platelets rich in growth factorsAtorvastatin loaded in PRGF fibrin scaffold | Drug | PRGF/ATV |
| ATV gelAlso: Atorvastatin gelAtorvastatin loaded in methyl cellulose gel | Drug | ATV gel |
Primary outcome
clinical measurements Ridge width
Time frame: 1 year
Ridge width
1 secondary outcome
clinical measurements ridge height
Time frame: 1 year
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 24 Sep 2018.
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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.
Khaled A Ghaffar, Professor study director
Ain Shams University
Ola M Ezzatt, Lecturer study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRGF/ATV and ATV gel in people with Socket Preservation, 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 3 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 24 Sep 2018. 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 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?
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?
clinical measurements Ridge width (time frame: 1 year). 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 24 Sep 2018.