PeriodontitisPhase 3NCT02447510
Growth Factors Release of PRF and PRGF
A Phase 3 study testing group 1 bio-oss bone xenograft, group 2 platelet rich in growth factor (autogenous platelet rich in growth factor) and group 3 platelet rich fibrin (autogenous platelet rich fibrin) in people with Periodontitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels which might be crucial to proper tissue repair and wound healing. However, the open usually contaminated nature of periodontal defects could affect negatively GF availability and activity. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- group 1 bio-oss bone xenograft, group 2 platelet rich in growth factor (autogenous platelet rich in growth factor) and group 3 platelet rich fibrin (autogenous platelet rich fibrin)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Mar 2015
- Phase
- Phase 3
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no systemic diseases which could influence platelet concentration or the outcome of therapy;
- good compliance with plaque control instructions following initial therapy;
- teeth involved were all vital with no mobility ;
- each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;
- selected intrabony defects (IBDs) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm;
- selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 5 mm at the site of intraosseous defects four weeks following initial cause-related therapy;
Show all 10Show fewer
- availability for the follow-up and maintenance program;
- absence of periodontal treatment during the previous year;
- absence of systemic medications that could affect healing or antibiotic treatment during the previous 6 months; and
- absence of occlusal interferences or open interproximal contacts (diastema, flaring or both).
Who cannot join
- 1. smokers and Pregnant females were excluded from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crevicular Fluid Growth Factors Release Profile Following the Use of Platelets Rich Fibrin (PRF) and Plasma Rich Growth Factors (PRGF) in Treating Periodontal Intrabony Defects (Randomized Clinical Trial)
Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels which might be crucial to proper tissue repair and wound healing. However, the open usually contaminated nature of periodontal defects could affect negatively GF availability and activity. To test this assumption, this study was designed to evaluate levels of VEGF and PDGF-BB in gingival crevicular fluid (GCF) during the early stages of healing of localized intrabony defects treated with platelet rich in growth factor (PRGF) and platelet rich fibrin (PRF) as compared with xenograft defect filling control.
Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this prospective, randomized and single blinded trial. Each patient contributed one interproximal defect that was randomly assigned to the bone substitute grafting control (n=10) G1, experimental PRGF (n=10) G2 and PRF (n=10) G3. Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were measured at baseline for patient enrollment. Gingival crevicular fluid (GCF) samples were collected on days 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels for sites treated by PRGF and PRF compared to that of the xenograft treated cases.
Read the detailed description
Owing to the lots of challenges that facing the use of recombinant growth factors in periodontal therapy, it is important to look for an alternative that combine ease of preparation and physiologic mode of delivery. Platelet concentrate has been developed for this purpose with many debates about the duration of GF availability in the defect area. Platelet-rich fibrin (PRF) is a leucocyte- and platelet-rich fibrin biomaterial. This dense fibrin membrane was claimed to releases high quantities of three main growth factors (Transforming Growth Factor b-1 (TGFβ-1), platelet derived growth factor AB, PDGF-AB; vascular endothelial growth factor, VEGF) and an important coagulation matricellular glycoprotein (thrombospondin-1, TSP-1). It has a natural fibrin framework that can protect growth factors from proteolysis. It is shown that PRF can release growth factors gradually and keep their activity to a relatively long period compared with platelet rich plasma (PRP). Levels of released TGF-1 and PDGF-AB markedly increased and reached the highest amount at day , then decreased mildly. In contrast, PRP experienced uncontrollable and short-term release of TGF-1 and PDGF-AB, which reached the highest amount at day 1 and then decreased rapidly.Clinically, it was found that PRF can improve clinical parameters associated with human intrabony periodontal defects and BPBM (bovine porous bone mineral) has the ability to augment effects of PRF in reducing pocket depth, improving clinical attachments levels, and promoting defect fill. On the other hand studies reported similar PD (probing depth) reduction, CAL (clinical attachment level) gain, and bone fill at sites treated with PRF or PRP compared with conventional open flap debridement.
Preparation rich in growth factors (PRGF-Endoret) technology was claimed to circumvent many of the limitations of other reported platelet-rich preparations. Sodium citrate and calcium chloride are used as an anticoagulant and a clot activator, respectively. Addition of calcium chloride promotes the formation of native thrombin, mimicking the physiological clotting process and enabling a more sustained release of growth factors, which might be crucial to proper tissue repair and wound healing. Moreover, this procedure obviates immunological reactions and the risk of disease transmission associated with the use of exogenous bovine thrombin. Anitua et al reported that PRGF contains a moderately elevated platelet concentration of ~6x105 platelets, which has been reported to induce the optimal biological benefit. Lower platelet concentrations can lead to suboptimal effects, whereas higher concentrations might have an inhibitory effect. PRGF application after extraction improved the healing process in diabetic patients by accelerating socket closure (epithelialization) and tissue maturation, proving the association between PRGF use and improved wound healing in diabetic patients.
In the present study it was proposed that the opened, constantly contaminated nature periodontal defects could be a source of continuous catabolic bacterial and tissue enzymes and binding proteins that affect platelet concentrate contained GF availability and activity. To confirm this assumption, this study was designed to evaluate levels of platelet derived growth factor - BB (PDGF-BB) and vascular endothelial cell growth factor (VEGF) in GCF during the early stages of healing for sites treated with PRF and PRGF in intrabony periodontal defects and to correlate GF levels with the clinical findings. This could figure out the potentials of these 2 commonly used platelet concentrate in the periodontal defects ecology.
- Conditions
- Periodontitis
- Being tested
- group 1 bio-oss bone xenograft, group 2 platelet rich in growth factor (autogenous platelet rich in growth factor), group 3 platelet rich fibrin (autogenous platelet rich fibrin)
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1 bio-oss bone xenograftProcedure or surgery
Also called bio-oss bone xenograft
bone substitute (bio-oss)
group 2 platelet rich in growth factor (autogenous platelet rich in growth factor)Procedure or surgery
Also called PRGF
platelet rich in growth factor (autogenous platelet rich in growth factor)
group 3 platelet rich fibrin (autogenous platelet rich fibrin)Procedure or surgery
Also called PRF
platelet rich fibrin (autogenous platelet rich fibrin)
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | bone substitute grafting material applied to the defect site control (n=10) Receives: Procedure: group 1 bio-oss bone xenograft |
| group 2 | Other | experimental platelet rich growth factor PRGF applied to the defect site (n=10) G2 Receives: Procedure: group 2 platelet rich in growth factor (autogenous platelet rich in growth factor) |
| group 3 | Other | platelet rich fibrin PRF applied to the defect site (n=10) G3. Receives: Procedure: group 3 platelet rich fibrin (autogenous platelet rich fibrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameters for the study were the crevicular fluid VEGF and PDGF-BB levels at 1 day
Measured: 1 day
crevicular fluid VEGF and PDGF-BB levels at 3day
Measured: 3 days
crevicular fluid VEGF and PDGF-BB levels at 7 day
Measured: 7 days
crevicular fluid VEGF and PDGF-BB levels at 14 day
Measured: 14 days
crevicular fluid VEGF and PDGF-BB levels at 21 day
Measured: 21 days
crevicular fluid VEGF and PDGF-BB levels at 30 day
Measured: 30 days
Secondary outcomes (5)
Secondary efficacy parameters included pocker depth at 6 months after surgery.
Measured: 6 months
Secondary efficacy parameters included pocker depth at 9 months after surgery.
Measured: 9 months
Secondary efficacy parameters included radiographic intrabony defect depth measurements 9 months after surgery.
Measured: 9 months
Secondary efficacy parameters included clinical attachment level at 6 months after surgery.
Measured: 6 months
Secondary efficacy parameters included clinical attachment level at 9 months after surgery.
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 posted19 May 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Y Gamal, Al-Azhar University
- Investigators
- Ahmed Y Gamal, PhD, Study chair, Ain Shams Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447510
- Sponsor's protocol ID
- Ain Shams Universty
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crevicular Fluid Growth Factors Release Profile Following the Use of Platelets Rich Fibrin (PRF) and Plasma Rich Growth Factors (PRGF) in Treating Periodontal Intrabony Defects (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT02447510
- Acronym / sponsor ID
- Ain Shams Universty
- Conditions
- Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 May 2015 (estimated)
- 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.
Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels which might be crucial to proper tissue repair and wound healing. However, the open usually contaminated nature of periodontal defects could affect negatively GF availability and activity. To test this assumption, this study was designed to evaluate levels of VEGF and PDGF-BB in gingival crevicular fluid (GCF) during the early stages of healing of localized intrabony defects treated with platelet rich in growth factor (PRGF) and platelet rich fibrin (PRF) as compared with xenograft defect filling control.
Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this prospective, randomized and single blinded trial. Each patient contributed one interproximal defect that was randomly assigned to the bone substitute grafting control (n=10) G1, experimental PRGF (n=10) G2 and PRF (n=10) G3. Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were measured at baseline for patient enrollment. Gingival crevicular fluid (GCF) samples were collected on days 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels for sites treated by PRGF and PRF compared to that of the xenograft treated cases.
Detailed description
Owing to the lots of challenges that facing the use of recombinant growth factors in periodontal therapy, it is important to look for an alternative that combine ease of preparation and physiologic mode of delivery. Platelet concentrate has been developed for this purpose with many debates about the duration of GF availability in the defect area. Platelet-rich fibrin (PRF) is a leucocyte- and platelet-rich fibrin biomaterial. This dense fibrin membrane was claimed to releases high quantities of three main growth factors (Transforming Growth Factor b-1 (TGFβ-1), platelet derived growth factor AB, PDGF-AB; vascular endothelial growth factor, VEGF) and an important coagulation matricellular glycoprotein (thrombospondin-1, TSP-1). It has a natural fibrin framework that can protect growth factors from proteolysis. It is shown that PRF can release growth factors gradually and keep their activity to a relatively long period compared with platelet rich plasma (PRP). Levels of released TGF-1 and PDGF-AB markedly increased and reached the highest amount at day , then decreased mildly. In contrast, PRP experienced uncontrollable and short-term release of TGF-1 and PDGF-AB, which reached the highest amount at day 1 and then decreased rapidly.Clinically, it was found that PRF can improve clinical parameters associated with human intrabony periodontal defects and BPBM (bovine porous bone mineral) has the ability to augment effects of PRF in reducing pocket depth, improving clinical attachments levels, and promoting defect fill. On the other hand studies reported similar PD (probing depth) reduction, CAL (clinical attachment level) gain, and bone fill at sites treated with PRF or PRP compared with conventional open flap debridement.
Preparation rich in growth factors (PRGF-Endoret) technology was claimed to circumvent many of the limitations of other reported platelet-rich preparations. Sodium citrate and calcium chloride are used as an anticoagulant and a clot activator, respectively. Addition of calcium chloride promotes the formation of native thrombin, mimicking the physiological clotting process and enabling a more sustained release of growth factors, which might be crucial to proper tissue repair and wound healing. Moreover, this procedure obviates immunological reactions and the risk of disease transmission associated with the use of exogenous bovine thrombin. Anitua et al reported that PRGF contains a moderately elevated platelet concentration of ~6x105 platelets, which has been reported to induce the optimal biological benefit. Lower platelet concentrations can lead to suboptimal effects, whereas higher concentrations might have an inhibitory effect. PRGF application after extraction improved the healing process in diabetic patients by accelerating socket closure (epithelialization) and tissue maturation, proving the association between PRGF use and improved wound healing in diabetic patients.
In the present study it was proposed that the opened, constantly contaminated nature periodontal defects could be a source of continuous catabolic bacterial and tissue enzymes and binding proteins that affect platelet concentrate contained GF availability and activity. To confirm this assumption, this study was designed to evaluate levels of platelet derived growth factor - BB (PDGF-BB) and vascular endothelial cell growth factor (VEGF) in GCF during the early stages of healing for sites treated with PRF and PRGF in intrabony periodontal defects and to correlate GF levels with the clinical findings. This could figure out the potentials of these 2 commonly used platelet concentrate in the periodontal defects ecology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Procedure: group 1 bio-oss bone xenograftbone substitute grafting material applied to the defect site control (n=10) |
| group 2 | Other | Procedure: group 2 platelet rich in growth factor (autogenous platelet rich in growth factor)experimental platelet rich growth factor PRGF applied to the defect site (n=10) G2 |
| group 3 | Other | Procedure: group 3 platelet rich fibrin (autogenous platelet rich fibrin)platelet rich fibrin PRF applied to the defect site (n=10) G3. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- no systemic diseases which could influence platelet concentration or the outcome of therapy;
- good compliance with plaque control instructions following initial therapy;
- teeth involved were all vital with no mobility ;
- each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;
- selected intrabony defects (IBDs) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm;
Key exclusion criteria (1 listed)
- 1. smokers and Pregnant females were excluded from participating in the study.
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 |
|---|---|---|
| group 1 bio-oss bone xenograftAlso: bio-oss bone xenograftbone substitute (bio-oss) | Procedure or surgery | group 1 |
| group 2 platelet rich in growth factor (autogenous platelet rich in growth factor)Also: PRGFplatelet rich in growth factor (autogenous platelet rich in growth factor) | Procedure or surgery | group 2 |
| group 3 platelet rich fibrin (autogenous platelet rich fibrin)Also: PRFplatelet rich fibrin (autogenous platelet rich fibrin) | Procedure or surgery | group 3 |
Primary outcome
The primary efficacy parameters for the study were the crevicular fluid VEGF and PDGF-BB levels at 1 day
Time frame: 1 day
crevicular fluid VEGF and PDGF-BB levels at 3day
Time frame: 3 days
crevicular fluid VEGF and PDGF-BB levels at 7 day
Time frame: 7 days
crevicular fluid VEGF and PDGF-BB levels at 14 day
Time frame: 14 days
crevicular fluid VEGF and PDGF-BB levels at 21 day
Time frame: 21 days
crevicular fluid VEGF and PDGF-BB levels at 30 day
Time frame: 30 days
5 secondary outcomes
Secondary efficacy parameters included pocker depth at 6 months after surgery.
Time frame: 6 months
Secondary efficacy parameters included pocker depth at 9 months after surgery.
Time frame: 9 months
Secondary efficacy parameters included radiographic intrabony defect depth measurements 9 months after surgery.
Time frame: 9 months
Secondary efficacy parameters included clinical attachment level at 6 months after surgery.
Time frame: 6 months
Secondary efficacy parameters included clinical attachment level at 9 months after surgery.
Time frame: 9 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 19 May 2015.
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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.
Ahmed Y Gamal, PhD study chair
Ain Shams Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing group 1 bio-oss bone xenograft, group 2 platelet rich in growth factor (autogenous platelet rich in growth factor) and group 3 platelet rich fibrin (autogenous platelet rich fibrin) in people with Periodontitis, run by Al-Azhar 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 10 inclusion and 1 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 19 May 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary efficacy parameters for the study were the crevicular fluid VEGF and PDGF-BB levels at 1 day (time frame: 1 day). The study lists 6 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 19 May 2015.