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CompletedNCT03274674Updated Sep 9, 2020

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

An interventional study of I-PRF in Periodontoclasia, Gingiva; Injury and Condition, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-09.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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 .

02

Conditions studied

  • Periodontoclasia
  • Gingiva; Injury
  • Condition
  • Blood Clot
  • Gingiva Disorder

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Keywords

  • PRF
  • I-PRF
  • Microneedle
  • Gingival Thickness
  • Injectable-Platelet-Rich-Fibrin
  • Platelet Rich Fibrin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Never smokers
  • Had no history of systemic disease
  • Aged ≥18 years old

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherI-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.

    Also known as: I-PRF and Microneedling

05

What researchers measure

Primary outcomes

  1. Gingival thickness (mm)

    Change in clinical measures of gingival thickness

    Time frame: 2 months

Secondary outcomes

  1. Plaque Index (PI)

    Change in clinical measures of gingival parameters

    Time frame: 2 months

  2. Gingival Index (GI)

    Change in clinical measures of gingival parameters

    Time frame: 2 months

  3. Bleeding on probing (BOP)

    Change in clinical measures of gingival parameters

    Time frame: 2 months

  4. Clinical attachment level (CAL)

    Change in clinical measures of gingival parameters

    Time frame: 2 months

  5. Probing pocket depth (PD)

    Change in clinical measures of gingival parameters

    Time frame: 2 months

06

Study locations

1 site
  • Zeliha Betül ÖZSAĞIR
    İstanbul, 34093, Turkey
07

References and documents

Publications

  • 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. PubMed 31912532 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03274674
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Apr 4, 2017
Primary completion
Jan 1, 2018
Completion
Jun 1, 2018
Last update
Sep 9, 2020

Study contacts

Zeliha Betül Özsağır
study chair · Bezmialem VU

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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