The Effect of Injectable Platelet-Rich Fibrin in Peri-implant Soft Tissue

NCT06753396 | Recruiting

• 1 other identifier: 2022-17/08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

An inadequate amount of peri-implant soft tissue results in more plaque accumulation around the implants, peri-implant mucositis, marginal bone loss, mucosal recession, and/or attachment loss. In the literature, there are studies evaluating the application of injectable platelet-rich fibrin to the gingiva and oral mucosa around teeth, but injectable platelet-rich fibrin application around implants has not been encountered. This study aimed to evaluate the effect of subgingival and submucosal application of injectable platelet-rich fibrin on peri-implant soft tissue phenotype in patients with inadequate peri-implant soft tissue phenotype.The study will include 80 systemically healthy and non-smoking patients/implants older than 18 years of age with insufficient peri-implant keratinized mucosa width and mucosal thickness who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology. There are two study groups according to peri-implant mucosa phenotype: Thin phenotype and thick phenotype. All patients will undergo the same procedure of injectable platelet-rich fibrin application

Conditions

Peri-Implant Tissues

Keywords

Peri-implant soft tissue; Injectable platelet-rich fibrin; Platelet-rich fibrin; Phenotype

Outcome Measures

Primary Outcomes (2)

• Peri-implant keratinized mucosa width

  To measure peri-implant keratinized mucosa width of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.

  1-year follow-up of all implants

• Peri-implant mucosa thickness

  To measure peri-implant mucosa thickness of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.

  1-year follow-up of all implants

Secondary Outcomes (1)

• Pink esthetic score

  1-year follow-up of all implants

Study Arms (2)

Thin phenotype

OTHER

Mucosa thickness is less than 1 mm and the visibility of the probe in the sulcus is high.

Procedure: Platelet rich fibrin

Thick phenotype

OTHER

Mucosa thickness is greater than 1 mm and visibility of the probe in the sulcus is low.

Procedure: Platelet rich fibrin

Interventions

Platelet rich fibrin PROCEDURE

The injectable platelet rich fibrin will be integrated into the tissue by subgingival and submucosal application to the keratinized gingiva of the implant sites with insufficient peri-implant soft tissue phenotype. Then, the prepared injectable platelet rich fibrin will be injected into the mucogingival junction apical to the keratinized gingival site. This procedure will be repeated 3 times in total, 1 time in 30 days for 3 months.

Also known as: Injectable plateler rich fibrin

Thick phenotype; Thin phenotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be over 18 years old
• The patient does not have any systemic disease
• Patients who do not smoke or who smoke less than 10 cigarettes
• Peri-implant keratinized mucosa width less than 2 mm
• Peri-implant mucosal thickness less than 2 mm

You may not qualify if:

• Being out of the defined age group
• Any systematic contraindication for periodontal surgery
• Patients who smoke more than 10 cigarettes per day
• Patients with adequate peri-implant keratinized mucosa width and mucosal thickness
• Pregnancy
• Patients taking medication that suppresses the immune system or impairs healing
• Patients taking medication that impairs the bleeding condition

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Faour NH, Dayoub S, Hajeer MY. Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial. Cureus. 2022 May 18;14(5):e25104. doi: 10.7759/cureus.25104. eCollection 2022 May.

  PMID: 35607316 BACKGROUND

• 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: 31912532 BACKGROUND

• Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.

  PMID: 28154995 BACKGROUND

• Frizzera F, Oliveira GJPL, Shibli JA, Moraes KC, Marcantonio EB, Marcantonio Junior E. Treatment of peri-implant soft tissue defects: a narrative review. Braz Oral Res. 2019 Sep 30;33(suppl 1):e073. doi: 10.1590/1807-3107bor-2019.vol33.0073. eCollection 2019.

  PMID: 31576957 BACKGROUND

• Bouri A Jr, Bissada N, Al-Zahrani MS, Faddoul F, Nouneh I. Width of keratinized gingiva and the health status of the supporting tissues around dental implants. Int J Oral Maxillofac Implants. 2008 Mar-Apr;23(2):323-6.

  PMID: 18548930 BACKGROUND

• Schrott AR, Jimenez M, Hwang JW, Fiorellini J, Weber HP. Five-year evaluation of the influence of keratinized mucosa on peri-implant soft-tissue health and stability around implants supporting full-arch mandibular fixed prostheses. Clin Oral Implants Res. 2009 Oct;20(10):1170-7. doi: 10.1111/j.1600-0501.2009.01795.x. Epub 2009 Aug 30.

  PMID: 19719741 BACKGROUND

• Chung DM, Oh TJ, Shotwell JL, Misch CE, Wang HL. Significance of keratinized mucosa in maintenance of dental implants with different surfaces. J Periodontol. 2006 Aug;77(8):1410-20. doi: 10.1902/jop.2006.050393.

  PMID: 16881810 BACKGROUND

• Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.

  PMID: 32710810 BACKGROUND

Study Officials

• Berceste Güler Ayyıldız, Assoc. Prof. Dr

  Kütahya Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Berceste Güler Ayyıldız

CONTACT

+05059359207; berceste.guler@ksbu.edu.tr

Seyma Eken

CONTACT

05518489820; seyma.eken@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: The study will include 80 systemically healthy and non-smoking patients/implants older than 18 years of age with insufficient peri-implant keratinized mucosa width and mucosal thickness who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology. There are two study groups according to peri-implant mucosa phenotype: Thin phenotype and thick phenotype.-Thin phenotype: Mucosa thickness is less than 1 mm and the visibility of the probe in the sulcus is high. -Thick phenotype: Mucosa thickness is greater than 1 mm and visibility of the probe in the sulcus is low.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 31, 2024
• Study Start: December 15, 2022
• Primary Completion: December 15, 2025
• Study Completion: April 15, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The work will be shared 6 months after publication
• Access Criteria: It will be shared in case the principal investigator is contacted.

Locations

TU (1)