NCT05591326

Brief Summary

Gingival recession is the term used to describe the apical positioning of the marginal gingiva from the enamel-cementum junction. Platelet-rich fibrin (PRF) has been routinely used for more than 20 years to increase keratinized gingival thickness and to close gingival recessions due to the growth factors it contains. In the literature, there are studies evaluating the application of i-PRF with the microneedling technique, but there is no study evaluating the creeping attachment phenomenon and the closure percentage of gingival recession with the creeping attachment after the application of this technique. The aim of this study is to evaluate the closure rates of gingival recession and creeping attachment phenomenon after i-PRF application with microneedling technique. Systemically healthy and non-smoker patients older than 18 years of age with gingival recession in mandibular anterior teeth and keratinized gingival deficiency will be included. Before the procedure, the venous blood taken from the patient will be centrifuged at 700 RPM for 3 minutes in glass and non-addition tubes to obtain i-PRF. The prepared i-PRF will be infected to the apical mucogingival junction of the keratinized gingival area. This process will be repeated once a month for 3 months. After the 3rd month, the horizontal and vertical gingival recession values will be evaluated and recorded at the end of 6 months and 1 year.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

September 6, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

October 19, 2022

Last Update Submit

March 6, 2025

Conditions

Keywords

i-PRFcreeping attachmentKeratinized gingival thicknessGingival Recession

Outcome Measures

Primary Outcomes (1)

  • The amount of root closure will be measured with the creeping attachment.

    The amount of root surface closure will be measured with the Creeping attachment in the 1st year following the injectable platelet-rich fibrin application procedure with the microneedling technique.

    1 year

Study Arms (1)

Cases in RT1 class according to gingival recession depth

EXPERIMENTAL

Depth of gingival recession in mandibular anterior teeth, according to the 2017 Periodontal Classification, cases in RT1 class will be included.

Procedure: i-PRF application procedure

Interventions

Local anesthesia will be applied to the area with gingival recession. Before the procedure, the venous blood taken from the patient will be centrifuged at 700 RPM for 3 minutes in glass and non-addition tubes to obtain i-PRF. i-TZF will be taken into a 2 cc injector. In 2020, Özsağır et al. Decortication, that is, microneedling, will be performed with insulin needle tips according to the protocol defined by Dr. Then the prepared i-PRF will be infected to the apical mucogingival junction of the keratinized gingival area. This process will be repeated once a month for 3 months. After the 3rd month, the horizontal and vertical gingival recession values will be evaluated and recorded at the end of 6 months and 1 year.

Cases in RT1 class according to gingival recession depth

Eligibility Criteria

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

You may qualify if:

  • Be over 18 years old
  • The patient does not have any systemic disease
  • Presence of at least one tooth with gingival recession in the mandibular or maxillary anterior region
  • Excessive dentin sensitivity and impaired esthetics associated with recession
  • Identifiable enamel-cementum junction in the gingival recession area
  • The tooth is alive and there are no irregularities, grooves, caries and restorations in the area to be treated.
  • No periodontal surgical treatment in the relevant areas in the last 24 months
  • Cases in RT1 class according to 2017 Periodontal Classification according to gingival recession depth

You may not qualify if:

  • Being outside the specified age range
  • Any contraindication for systematic periodontal surgery
  • Presence of caries, restoration, root concavity in the area to be treated
  • Patients who smoke more than 10 cigarettes per day
  • Patients who use drugs that suppress the immune system or impair healing
  • Patients using drugs that impair bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (3)

  • Wan W, Zhong H, Wang J. Creeping attachment: A literature review. J Esthet Restor Dent. 2020 Dec;32(8):776-782. doi: 10.1111/jerd.12648. Epub 2020 Sep 8.

    PMID: 32896991BACKGROUND
  • Ahrlund-Richter L, Wikstrom AC, Ramqvist T, Klein E. The Lyt phenotype of the T cells in an antitumor adoptive transfer differs for "parent to F1" and "parent to parent" combinations. Cell Immunol. 1984 Jul;86(2):575-82. doi: 10.1016/0008-8749(84)90416-7.

    PMID: 6610486BACKGROUND
  • Miron RJ, Moraschini V, Del Fabbro M, Piattelli A, Fujioka-Kobayashi M, Zhang Y, Saulacic N, Schaller B, Kawase T, Cosgarea R, Jepsen S, Tuttle D, Bishara M, Canullo L, Eliezer M, Stavropoulos A, Shirakata Y, Stahli A, Gruber R, Lucaciu O, Aroca S, Deppe H, Wang HL, Sculean A. Use of platelet-rich fibrin for the treatment of gingival recessions: a systematic review and meta-analysis. Clin Oral Investig. 2020 Aug;24(8):2543-2557. doi: 10.1007/s00784-020-03400-7. Epub 2020 Jun 26.

    PMID: 32591868BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Berceste Güler

    Kütahya Health Sciences University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

September 6, 2021

Primary Completion

September 5, 2025

Study Completion

December 4, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

IPD will be shared in case of contacting the research coordinator.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After the study is completed and published
Access Criteria
After the study is completed and published, the IPD will be shared if the research coordinator is contacted.

Locations