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

NCT02380872 | Completed

• 1 other identifier: Ege Uni School of Dentistry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

Gingival recession; fibrin; connective tissue; gingival crevicular fluid; matrix metalloproteinase; cytokine

Outcome Measures

Primary Outcomes (4)

• 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 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 TIMP-1 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

Secondary Outcomes (1)

• Gingival recession depth

  6 months

Study Arms (2)

Connective tissue graft

ACTIVE COMPARATOR

Connective tissue graft Soft tissue harvested from palatum of the subjects.

Procedure: Connective tissue graft

Platelet Rich Fibrin

EXPERIMENTAL

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Procedure: Platelet Rich Fibrin

Interventions

Connective tissue graft PROCEDURE

gingival recession treated with connective tissue graft

Connective tissue graft

Platelet Rich Fibrin PROCEDURE

gingival recession treated with platelet rich fibrin

Platelet Rich Fibrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Dentistry Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Gülnihal Eren, PhD. Dr.

  Ege University School of Dentistry

  PRINCIPAL INVESTIGATOR

• Gül Atilla, Professor

  Ege University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: March 5, 2015
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

TU (1)