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

NCT ID: NCT03274674

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2018-06-01

Brief Summary

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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

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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 .

Conditions

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Periodontoclasia Gingiva; Injury Condition Blood Clot Gingiva Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded, Parallel group, Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

I-PRF

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

I-PRF

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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I-PRF and Microneedling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeliha Betül Özsağır

Role: STUDY_CHAIR

Bezmialem VU

Locations

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Zeliha Betül ÖZSAĞIR

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 31912532 (View on PubMed)

Other Identifiers

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boz002

Identifier Type: -

Identifier Source: org_study_id

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