Alveolar Socket PreservationsPhase 4NCT03231137
Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination
A Phase 4 study testing PRGF/ATV, ATV gel and PRF in people with Alveolar Socket Preservations, run by Ain Shams University.
Trial summary
This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Socket Preservations
- What is being tested?
- PRGF/ATV, ATV gel and PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2012to 10 Jul 2017
- 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
- 1. Both genders, aged from 20 to 50 years
- 2. Patients free from any systemic diseases
- 3. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated for crown preparation such as tooth with subgingival caries, broken roots, periodontally affected teeth, remaining roots) in the premolar and first molar area.
- 4. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels in relation to cement-enamel junction of the pre-extracted tooth and remain intact postextraction as determined by clinical examination and periapical radiographs
- 5. Patient agreed to sign a written consent after explanation of study nature.
Who cannot join
- 1. Smokers.
- 2. Pregnant and breast feeding females.
- 3. Previous radiation, chemotherapy, or immunosuppressive treatments.
- 4. Known hypersensitivity to statin drugs.
- 5. Teeth with periapical infections, type II or III sockets or with dehiscence or fenestrations
- 6. Vulnerable groups such as (Prisoners and handicapped or mentally disabled)
About this study
Official title: Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)
This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.
Read the detailed description
Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as part of the natural physiological healing process. There are many techniques in the literature used for socket preservation as bone grafts, barrier membranes, immediate implant and socket shield. Many other techniques also are used such as bone and tissue healing promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the widely used group of cholesterol lowering drugs which also increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area of growth factors, there is no high-quality evidence to either support or refuse their use.
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.
- Conditions
- Alveolar Socket Preservations
- Being tested
- PRGF/ATV, ATV gel, PRF, PRGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF/ATVCombination product
Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold
ATV gelDrug
Atorvastatin gel
PRFBiological
Platelet rich fibrin
PRGFBiological
plasma rich in growth factor
| Study group | Role | What they receive |
|---|---|---|
| PRGF/ATV | Experimental | Included 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket. Receives: Combination Product: PRGF/ATV |
| ATV gel | Experimental | Included 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket. Receives: Drug: ATV gel |
| PRF | Experimental | Included 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket. Receives: Biological: PRF |
| PRGF | Experimental | Included 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket. Receives: Biological: PRGF |
| Control | No intervention | Spontaneously healed socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative ridge height
(Measured from stent reference point to the crest of the buccal or palatal plate of bone)
Measured: baseline (immediately after extraction) - After 2 months
Ridge width
(Measured from the buccal to palatal plate of bone using bone caliper)
Measured: baseline (immediately after extraction) - After 2 months
Secondary outcomes (2)
Collagen surface area
Measured: after 2 months
Average tabecular size
Measured: after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start16 Jun 2012
- Primary completion12 Mar 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Socket PreservationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Ezzatt, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231137
- Sponsor's protocol ID
- ASU-OMP-2012-9
- Status last verified
- Jul 2017
- First submitted
- 25 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)
- ClinicalTrials.gov ID
- NCT03231137
- Acronym / sponsor ID
- ASU-OMP-2012-9
- Conditions
- Alveolar Socket Preservations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Jun 2012 (actual)
- Primary completion
- 12 Mar 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 27 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.
This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.
Detailed description
Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as part of the natural physiological healing process. There are many techniques in the literature used for socket preservation as bone grafts, barrier membranes, immediate implant and socket shield. Many other techniques also are used such as bone and tissue healing promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the widely used group of cholesterol lowering drugs which also increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area of growth factors, there is no high-quality evidence to either support or refuse their use.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PRGF/ATV | Experimental | Combination Product: PRGF/ATVIncluded 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket. |
| ATV gel | Experimental | Drug: ATV gelIncluded 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket. |
| PRF | Experimental | Biological: PRFIncluded 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket. |
| PRGF | Experimental | Biological: PRGFIncluded 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket. |
| Control | No intervention | –Spontaneously healed socket |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Both genders, aged from 20 to 50 years
- 2. Patients free from any systemic diseases
- 3. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated for crown preparation such as tooth with subgingival caries, broken roots, periodontally affected teeth, remaining roots) in the premolar and first molar area.
- 4. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels in relation to cement-enamel junction of the pre-extracted tooth and remain intact postextraction as determined by clinical examination and periapical radiographs
- 5. Patient agreed to sign a written consent after explanation of study nature.
Key exclusion criteria (6 listed)
- 1. Smokers.
- 2. Pregnant and breast feeding females.
- 3. Previous radiation, chemotherapy, or immunosuppressive treatments.
- 4. Known hypersensitivity to statin drugs.
- 5. Teeth with periapical infections, type II or III sockets or with dehiscence or fenestrations
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/ATVAtorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold | Combination product | PRGF/ATV |
| ATV gelAtorvastatin gel | Drug | ATV gel |
| PRFPlatelet rich fibrin | Biological | PRF |
| PRGFplasma rich in growth factor | Biological | PRGF |
Primary outcome
Relative ridge height
Time frame: baseline (immediately after extraction) - After 2 months
(Measured from stent reference point to the crest of the buccal or palatal plate of bone)
Ridge width
Time frame: baseline (immediately after extraction) - After 2 months
(Measured from the buccal to palatal plate of bone using bone caliper)
2 secondary outcomes
Collagen surface area
Time frame: after 2 months
Average tabecular size
Time frame: after 2 months
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 27 Jul 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRGF/ATV, ATV gel and PRF in people with Alveolar Socket Preservations, run by Ain Shams University.
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 6 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Relative ridge height (time frame: baseline (immediately after extraction) - After 2 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 27 Jul 2017.