Perforated Barrier Membranes Maintain Physiologic Gingival Crevicular Fluid Growth Factor Levels

NCT02168322 | Completed DMC

• 1 other identifier: Al Azhar universty
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

growth factors; periodontal regeneration; modefied perforated membranes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• clinical corelation with the growth factors levels

  30 days

Study Arms (1)

collagen membranes

EXPERIMENTAL

collagen barrier that help in isolating unwanted tissues in periodontal regneration

Device: collagen membrane

Interventions

collagen membrane DEVICE

bovine collagen membrane used for selective tissue regeneration

Also known as: guided tissue membranes, guided bone regeneration, occlusive membranes

collagen membranes

Eligibility Criteria

• Age: 26 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no systemic diseases which could influence the outcome of the therapy;
• good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with no mobility ;
• \) 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).

You may not qualify if:

• Pregnant females were excluded from participating in the study

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ain Shams Universty

Cairo, Nasr City, 1123, Egypt

Location

Related Publications (1)

• 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.

  PMID: 23003916 BACKGROUND

Study Officials

• Ahmed Y Gamal, PhD

  Ain Shams Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 7, 2014
• First Posted: June 20, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

EG (1)