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Completed

NCT Number: NCT03274674

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

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

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Key information

Conditions

Periodontoclasia Blood Clot Cardiovascular Diseases Condition Disease Embolism and Thrombosis Gingiva Disorder Gingiva; Injury Gingival Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases Thrombosis Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeliha Betül ÖZSAĞIR

Istanbul, 34093, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-PRF

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.

Other names: I-PRF and Microneedling

Primary outcomes

  1. Gingival thickness (mm)

    Time frame: 2 months

    Change in clinical measures of gingival thickness

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: 2 months

    Change in clinical measures of gingival parameters

  2. Gingival Index (GI)

    Time frame: 2 months

    Change in clinical measures of gingival parameters

  3. Bleeding on probing (BOP)

    Time frame: 2 months

    Change in clinical measures of gingival parameters

  4. Clinical attachment level (CAL)

    Time frame: 2 months

    Change in clinical measures of gingival parameters

  5. Probing pocket depth (PD)

    Time frame: 2 months

    Change in clinical measures of gingival parameters

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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