The Effect of Using Injectable Platelet-rich Fibrin on Root Surface Closure in Patients with Gingival Recession.
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2021
CompletedFirst Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2025
CompletedMarch 10, 2025
March 1, 2025
4 years
October 19, 2022
March 6, 2025
Conditions
Keywords
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
EXPERIMENTALDepth of gingival recession in mandibular anterior teeth, according to the 2017 Periodontal Classification, cases in RT1 class will be included.
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.
Eligibility Criteria
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
- Berceste Gulerlead
Study Sites (1)
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100, Turkey (Türkiye)
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: 32896991BACKGROUNDAhrlund-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: 6610486BACKGROUNDMiron 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berceste Güler
Kütahya Health Sciences University Faculty of Dentistry
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
- 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.
IPD will be shared in case of contacting the research coordinator.