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Completed

NCT Number: NCT02380872

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Dentistry Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

connective tissue graft

Procedure

gingival recession treated with connective tissue graft

Platelet Rich Fibrin

Procedure

gingival recession treated with platelet rich fibrin

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Gingival recession depth

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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