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

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ClinicalTrials.gov Identifier: NCT03274674
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Periodontoclasia Gingiva; Injury Condition Blood Clot Gingiva Disorder Other: I-PRF Not Applicable

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 .

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, Parallel group, Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : June 1, 2018

Arm Intervention/treatment
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.
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.
Other Name: I-PRF and Microneedling

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.
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.
Other Name: I-PRF and Microneedling




Primary Outcome Measures :
  1. Gingival thickness (mm) [ Time Frame: 2 months ]
    Change in clinical measures of gingival thickness


Secondary Outcome Measures :
  1. Plaque Index (PI) [ Time Frame: 2 months ]
    Change in clinical measures of gingival parameters

  2. Gingival Index (GI) [ Time Frame: 2 months ]
    Change in clinical measures of gingival parameters

  3. Bleeding on probing (BOP) [ Time Frame: 2 months ]
    Change in clinical measures of gingival parameters

  4. Clinical attachment level (CAL) [ Time Frame: 2 months ]
    Change in clinical measures of gingival parameters

  5. Probing pocket depth (PD) [ Time Frame: 2 months ]
    Change in clinical measures of gingival parameters



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274674


Locations
Turkey
Zeliha Betül ÖZSAĞIR
İstanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Study Chair: Zeliha Betül Özsağır Bezmialem VU

Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03274674     History of Changes
Other Study ID Numbers: boz002
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bezmialem Vakif University:
PRF
I-PRF
Microneedle
Gingival Thickness
Injectable-Platelet-Rich-Fibrin
Platelet Rich Fibrin

Additional relevant MeSH terms:
Thrombosis
Gingival Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases