Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective tissue graft
Platelet Rich Fibrin
Sponsored by
About this trial
This is an interventional diagnostic trial for Gingival Recession focused on measuring Gingival recession, fibrin, connective tissue, gingival crevicular fluid, matrix metalloproteinase, cytokine
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.
Sites / Locations
- Ege University School of Dentistry Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Connective tissue graft
Platelet Rich Fibrin
Arm Description
Connective tissue graft Soft tissue harvested from palatum of the subjects.
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Outcomes
Primary Outcome Measures
Change from Baseline in MMP-8 gingival crevicular fluid level at 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
Change from Baseline in TIMP-1 gingival crevicular fluid level at 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
Secondary Outcome Measures
Gingival recession depth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02380872
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival recession, fibrin, connective tissue, gingival crevicular fluid, matrix metalloproteinase, cytokine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue graft
Arm Type
Active Comparator
Arm Description
Connective tissue graft Soft tissue harvested from palatum of the subjects.
Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
gingival recession treated with connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Fibrin
Intervention Description
gingival recession treated with platelet rich fibrin
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Gingival recession depth
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülnihal Eren, PhD. Dr.
Organizational Affiliation
Ege University School of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gül Atilla, Professor
Organizational Affiliation
Ege University School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Ege University School of Dentistry Department of Periodontology
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
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Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
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