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

September 8, 2020 updated by: Bezmialem Vakif University

New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34093
        • Zeliha Betül ÖZSAĞIR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • I-PRF and Microneedling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Zeliha Betul Özsağır, Bezmialem VU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (ACTUAL)

September 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • boz002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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