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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Platelet Rich Fibrin; Procedure: Connective tissue graft

• Registration Number: NCT02380872
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Study First Submitted: 2015-02-14
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Fibrin	Platelet Rich Fibrin	Autogenous platelet and leukocyte fibrin material was obtained from blood.
Connective tissue graft	Connective tissue graft	Connective tissue graft Soft tissue harvested from palatum of the subjects.

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Gingival recession depth	6 months

Trial Locations

Locations (1)

Ege University School of Dentistry Department of Periodontology; 🇹🇷 İzmir, Turkey