Growth Factors Release of PRF and PRGF
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)
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedMay 19, 2015
May 1, 2015
6 months
May 6, 2015
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (6)
The primary efficacy parameters for the study were the crevicular fluid VEGF and PDGF-BB levels at 1 day
1 day
crevicular fluid VEGF and PDGF-BB levels at 3day
3 days
crevicular fluid VEGF and PDGF-BB levels at 7 day
7 days
crevicular fluid VEGF and PDGF-BB levels at 14 day
14 days
crevicular fluid VEGF and PDGF-BB levels at 21 day
21 days
crevicular fluid VEGF and PDGF-BB levels at 30 day
30 days
Secondary Outcomes (5)
Secondary efficacy parameters included pocker depth at 6 months after surgery.
6 months
Secondary efficacy parameters included pocker depth at 9 months after surgery.
9 months
Secondary efficacy parameters included radiographic intrabony defect depth measurements 9 months after surgery.
9 months
Secondary efficacy parameters included clinical attachment level at 6 months after surgery.
6 months
Secondary efficacy parameters included clinical attachment level at 9 months after surgery.
9 months
Study Arms (3)
group 1
OTHERbone substitute grafting material applied to the defect site control (n=10)
group 2
OTHERexperimental platelet rich growth factor PRGF applied to the defect site (n=10) G2
group 3
OTHERplatelet rich fibrin PRF applied to the defect site (n=10) G3.
Interventions
bone substitute (bio-oss)
platelet rich in growth factor (autogenous platelet rich in growth factor)
platelet rich fibrin (autogenous platelet rich fibrin)
Eligibility Criteria
You may qualify if:
- 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;
- 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).
You may not qualify if:
- \. smokers and Pregnant females were excluded from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Universty
Cairo, Nasr City, 1123, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Y Gamal, PhD
Ain Shams Universty
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 19, 2015
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05