Vascular Endothelial Growth Factor Overexpression Clinical Trial
Official title:
Perforated Barrier Membranes Maintain Physiologic Gingival Crevicular Fluid Growth Factor Levels During Treatment of Intrabony Defects: An In Vivo Proof-of-Principle Study
Verified date | May 2015 |
Source | Al-Azhar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
Membrane modifecation:
Guided tissue membrane perforations may serve as a more biologic scaffold that could allow
for the free passage of biologic mediators from the periosteum and overlying gingival
connective tissue into the periodontal defects.
Study hyposethis:
To test this hyposthesis, this study was designed to evaluate levels of vascular endothelial
cell growth factors and platlet derived growth factors in gingival crevicular fluid (GCF)
during the early stages of healing for localized intrabony defects treated with modified
perforated membranes (MPMs), occlusive membranes (OMs) as compared to open flap debridement
control (OFD).
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 experimental modified perforated membrane group (10
sites), occlusive membrane group (10 sites) or open flap debridement control (10 sites).
Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the
intrabony depth of the defect (IBD) were measured at baseline for patients enrollment.
Gingival crevicular fluid (GCF) samples were collected on day 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 MPMs or OM compared to that of the OFD treated cases.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 26 Years to 49 Years |
Eligibility |
Inclusion Criteria: 1. no systemic diseases which could influence the outcome of the therapy; 2. good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with no mobility ; 4) each subject contributed a single 2 or 3-wall intrabony interproximal defects around premolar or molar teeth without furcation involvement; 5) selected 2- or 3-wall intrabony defects (IBC) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of= 3 mm 6) 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; 6) availability for the follow-up and maintenance program; 7) absence of periodontal treatment during the previous year; 8) absence of systemic medications that could affect healing or antibiotic treatment during the previous 6 months; and 9) absence of occlusal interferences, open interproximal contacts (diastema, flaring or both). Exclusion Criteria: - Pregnant females were excluded from participating in the study |
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Universty | Cairo | Nasr City |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
Gamal AY, Iacono VJ. Enhancing guided tissue regeneration of periodontal defects by using a novel perforated barrier membrane. J Periodontol. 2013 Jul;84(7):905-13. doi: 10.1902/jop.2012.120301. Epub 2012 Sep 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | platelet derived growth factor and endothelial cell growth factor levels in the gigival cervicular fluid during Treatment of Intrabony Defects: An in Vivo Proof-of-Principle Study | membrane perforations could provide more physiologic growth factors concentrations in the defect area for their optimal effects. To test this assumption in a more controlled manner with a standard growth factors levels of open flap debridement treated sites, the objective of this study was to evaluate levels of platelet derived growth factors - BB (PDGF-BB) and vascular endothelial cell growth factor (VCGF) in GCF during the early stages of healing for sites treated with MPM or OM as compared with those sites treated with control OFD. | 30 days | Yes |
Secondary | clinical corelation with the growth factors levels | could this controled level of the growth factors acheived with perforated membrane has a clinical impact | 30 days | Yes |
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