Clinical Trial: Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cytokine (IL-1ß) and Matrix Metalloproteinase (MMP) Levels in Gingival Crevicular Fluid After Use of Platelet Rich Fibrin or Connective Tissue Graft in the Treatment of Localized The aim of this study was to evaluate the effect of PRF by assessing gingival crevicular fluid (GCF) levels of MMP-8, MMP-9, tissue inhibitor of matrix metalloproteinase (TIMP-1) and interleukin-1beta (IL-1β) during the early and late stages of healing following coronally advanced flap (CAF) plus PRF or CAF plus connective tissue graft (CTG) treatment.

Primary outcome variables were biochemical parameters, such as: GCF MMP-8, -9, TIMP-1 and IL-1β levels. The secondary outcome variables were change in gingival recession expressed as recession reduction in millimeters at follow-up visits.

Sample size has been estimated in 24 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Biochemical parameters: GCF samples were obtained from each recession defect in each subject immediately prior to treatment of recessions and at 10 days, 1 month, 3 months and 6 months after surgery.

Periodontal parameters including probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), and keratinized tissue width (KTW),were assessed by a calibrated examiner. At baseline and at 6 months, PD, RD, RW and KTW were evaluated by clinical assessment.

Follow-up of subjects: 6 months.


Sponsor: Ege University

Current Primary Outcome:

  • Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months [ Time Frame: Baseline, 10 days, 1, 3 and 6 months ]
  • Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months [ Time Frame: Baseline, 10 days, 1, 3 and 6 months ]
  • Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months [ Time Frame: Baseline, 10 days, 1, 3 and 6 months ]
  • Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months [ Time Frame: Baseline, 10 days, 1, 3 and 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Gingival recession depth [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Ege University

Dates:
Date Received: February 14, 2015
Date Started: October 2012
Date Completion:
Last Updated: March 2, 2015
Last Verified: March 2015