NCT03274674

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 5, 2017

Last Update Submit

September 8, 2020

Conditions

PeriodontoclasiaGingiva; InjuryConditionBlood ClotGingiva Disorder

Keywords

PRFI-PRFMicroneedleGingival ThicknessInjectable-Platelet-Rich-FibrinPlatelet Rich Fibrin

Outcome Measures

Primary Outcomes (1)

  • Gingival thickness (mm)

    Change in clinical measures of gingival thickness

    2 months

Secondary Outcomes (5)

  • Plaque Index (PI)

    2 months

  • Gingival Index (GI)

    2 months

  • Bleeding on probing (BOP)

    2 months

  • Clinical attachment level (CAL)

    2 months

  • Probing pocket depth (PD)

    2 months

Study Arms (2)

I-PRF

EXPERIMENTAL

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

I-PRF and Microneedling

ACTIVE COMPARATOR

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

I-PRFOTHER

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
I-PRFI-PRF and Microneedling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeliha Betül ÖZSAĞIR

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31912532DERIVED

MeSH Terms

Conditions

Wounds and InjuriesDiseaseThrombosisGingival Diseases

Interventions

proliferation regulatory factors, human urinePercutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Zeliha Betül Özsağır

    Bezmialem VU

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Blinded, Parallel group, Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

April 4, 2017

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

TU(1)