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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380872
• Other study ID #: Ege Uni School of Dentistry
• Status: Completed
• Phase: N/A
• First received: February 14, 2015
• Last updated: March 2, 2015
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Connective tissue graft
gingival recession treated with connective tissue graft
• Platelet Rich Fibrin
gingival recession treated with platelet rich fibrin

Locations

Country	Name	City	State
Turkey	Ege University School of Dentistry Department of Periodontology	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months		Baseline, 10 days, 1, 3 and 6 months	No
Primary	Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months		Baseline, 10 days, 1, 3 and 6 months	No
Primary	Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months		Baseline, 10 days, 1, 3 and 6 months	No
Primary	Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months		Baseline, 10 days, 1, 3 and 6 months	No
Secondary	Gingival recession depth		6 months	No