An interventional study of Connective tissue graft and Platelet Rich Fibrin in Gingival Recession, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Ege University · Not applicable, Interventional, and Diagnostic
The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus connective tissue graft. As PRF consists of several growth factors, it may enhance the healing potential of soft tissues, the investigators hypothesized that using PRF in the treatment of gingival recessions might regulate inflammation and promote wound healing.
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Connective tissue graft Soft tissue harvested from palatum of the subjects.
Procedure: Connective tissue graft
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Procedure: Platelet Rich Fibrin
gingival recession treated with connective tissue graft
gingival recession treated with platelet rich fibrin
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
Gingival recession depth
Time frame: 6 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Ege University