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

NCT ID: NCT02380872

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Connective tissue graft

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

Group Type ACTIVE_COMPARATOR

Connective tissue graft

Intervention Type PROCEDURE

gingival recession treated with connective tissue graft

Platelet Rich Fibrin

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Group Type EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type PROCEDURE

gingival recession treated with platelet rich fibrin

Interventions

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Connective tissue graft

gingival recession treated with connective tissue graft

Intervention Type PROCEDURE

Platelet Rich Fibrin

gingival recession treated with platelet rich fibrin

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gülnihal Eren, Research Asisstant

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülnihal Eren, PhD. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ege University School of Dentistry

Gül Atilla, Professor

Role: STUDY_DIRECTOR

Ege University School of Dentistry

Locations

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Ege University School of Dentistry Department of Periodontology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ege Uni School of Dentistry

Identifier Type: -

Identifier Source: org_study_id

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