Clinical trial NCT02380872: Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
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 Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival recession
fibrin
connective tissue
gingival crevicular fluid
matrix metalloproteinase
cytokine
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Similar bilateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
* Identifiable cementoenamel junction
* Age ≥ 18 years
* Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
* No periodontal surgical treatment in the previous 24 months on the involved sites
* Sufficient palatal donor tissue for the indicated SCTG.

Exclusion Criteria:

* Smoking
* Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
* Molar, mobile or teeth with crown or filling were also excluded.

Primary outcomes:
measure: Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
timeFrame: Baseline, 10 days, 1, 3 and 6 months
measure: Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
timeFrame: Baseline, 10 days, 1, 3 and 6 months
measure: Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
timeFrame: Baseline, 10 days, 1, 3 and 6 months
measure: Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months
timeFrame: Baseline, 10 days, 1, 3 and 6 months
Secondary outcomes:
measure: Gingival recession depth
timeFrame: 6 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Dentistry Department of Periodontology
Study officials:
affiliation: Ege University School of Dentistry
name: Gülnihal Eren, PhD. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University School of Dentistry
name: Gül Atilla, Professor
role: STUDY_DIRECTOR
References: