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Perforated Barrier Membranes Maintain Physiologic Gingival Crevicular Fluid Growth Factor Levels

NCT02168322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Vascular Endothelial Growth Factor Overexpression
  • Membrane Alteration

Interventions

DEVICE

collagen membrane

bovine collagen membrane used for selective tissue regeneration

DEVICE

collagen membrane

collagen bovine occlusive membrane for selective tissue regneration

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Ahmed Y Gamal, PhD · Ain Shams Universty

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
26 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168322 on ClinicalTrials.gov