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

Primary Purpose

Periodontoclasia, Gingiva; Injury, Condition

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
I-PRF
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontoclasia focused on measuring PRF, I-PRF, Microneedle, Gingival Thickness, Injectable-Platelet-Rich-Fibrin, Platelet Rich Fibrin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zeliha Betül ÖZSAĞIR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I-PRF

I-PRF and Microneedling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gingival thickness (mm)
Change in clinical measures of gingival thickness

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2017
Last Updated
September 8, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03274674
Brief Title
Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype
Official Title
New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

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

5. Study Description

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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontoclasia, Gingiva; Injury, Condition, Blood Clot, Gingiva Disorder
Keywords
PRF, I-PRF, Microneedle, Gingival Thickness, Injectable-Platelet-Rich-Fibrin, Platelet Rich Fibrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded, Parallel group, Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
I-PRF and Microneedling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
I-PRF
Other Intervention Name(s)
I-PRF and Microneedling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingival thickness (mm)
Description
Change in clinical measures of gingival thickness
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Plaque Index (PI)
Description
Change in clinical measures of gingival parameters
Time Frame
2 months
Title
Gingival Index (GI)
Description
Change in clinical measures of gingival parameters
Time Frame
2 months
Title
Bleeding on probing (BOP)
Description
Change in clinical measures of gingival parameters
Time Frame
2 months
Title
Clinical attachment level (CAL)
Description
Change in clinical measures of gingival parameters
Time Frame
2 months
Title
Probing pocket depth (PD)
Description
Change in clinical measures of gingival parameters
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeliha Betül Özsağır
Organizational Affiliation
Bezmialem VU
Official's Role
Study Chair
Facility Information:
Facility Name
Zeliha Betül ÖZSAĞIR
City
İstanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31912532
Citation
Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
Results Reference
derived

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

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