- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380872
Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İzmir, Turkey, 35100
- Ege University School of Dentistry Department of Periodontology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Connective tissue graft
Connective tissue graft Soft tissue harvested from palatum of the subjects.
|
gingival recession treated with connective tissue graft
|
|
EXPERIMENTAL: Platelet Rich Fibrin
Autogenous platelet and leukocyte fibrin material was obtained from blood.
|
gingival recession treated with platelet rich fibrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
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
|
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
|
Baseline, 10 days, 1, 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gingival recession depth
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülnihal Eren, PhD. Dr., Ege University School of Dentistry
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ege Uni School of Dentistry
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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