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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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2017, registered Sep 2017).
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

Keywords

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

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 29 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Zeliha Betül ÖZSAĞIR
    İstanbul, 34093, Turkey
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Jan 2018, 8 months.

Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 8 months is below that.

Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.

Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 7, 2017
StartActual
Apr 4, 2017
Primary completionActual
Jan 1, 2018
CompletionActual
Jun 1, 2018
Last update
Sep 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03274674
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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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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