Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype

Overview

The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures

Full Title of Study: “New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2018

Detailed Description

Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .

Interventions

  • Other: I-PRF
    • Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.

Arms, Groups and Cohorts

  • Experimental: I-PRF
    • Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Apply once a week and one month after the end of the injections, the patient will be called to the control.
  • Active Comparator: I-PRF and Microneedling
    • Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.

Clinical Trial Outcome Measures

Primary Measures

  • Gingival thickness (mm)
    • Time Frame: 2 months
    • Change in clinical measures of gingival thickness

Secondary Measures

  • Plaque Index (PI)
    • Time Frame: 2 months
    • Change in clinical measures of gingival parameters
  • Gingival Index (GI)
    • Time Frame: 2 months
    • Change in clinical measures of gingival parameters
  • Bleeding on probing (BOP)
    • Time Frame: 2 months
    • Change in clinical measures of gingival parameters
  • Clinical attachment level (CAL)
    • Time Frame: 2 months
    • Change in clinical measures of gingival parameters
  • Probing pocket depth (PD)
    • Time Frame: 2 months
    • Change in clinical measures of gingival parameters

Participating in This Clinical Trial

Inclusion Criteria

  • Never smokers – Had no history of systemic disease – Aged ≥18 years old Exclusion Criteria:

  • Patients with a history of diabetes mellitus or systemic disease – Patients who were under any medication that was known to influence periodontal tissues – Patients with hormonal changes such as pregnancy or lactation – Toothless individuals – Patients who were clotting disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zeliha Betül Özsağır, Study Chair, Bezmialem VU

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