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Peri-Implant TissuesNCT06753396

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

A study testing Platelet rich fibrin in people with Peri-Implant Tissues, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peri-Implant Tissues
What is being tested?
Platelet rich fibrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2022to 15 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Berceste Güler Ayyıldız contact

+05059359207

berceste.guler@ksbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Kütahya Health Sciences University Faculty of Dentistry

    Kütahya, 43100

    Berceste Guler Ayyıldız, Associate Professor Dr., 905059359207, berceste43@gmail.com

    Seyma Eken, Lect. Dr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Injectable Platelet-Rich Fibrin on Peri-Implant Soft Tissue Phenotype

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

Read the detailed description

The peri-implant soft tissue phenotype comprises keratinized mucosal width mucosal thickness, and supracrestal tissue height. Peri-implant soft tissue has been at the center of debate for the last decade, playing a critical role in implant esthetics and peri-implant health. Various methods such as bone grafts, autologous soft tissue grafts, non-cellular dermal matrix, autologous platelet concentrates, and hyaluronic acid are used to increase the peri-implant soft tissue phenotype. Most of these methods are surgical and invasive. Recently, the use of autologous platelet concentrates has been proposed to support oral soft and hard tissue regeneration in regenerative periodontology and implant dentistry. Injectable platelet-rich fibrin from autologous platelet concentrates is a bioactive agent obtained by centrifugation at low speed. Its high content of white blood cells and high concentration of growth factors provide an important advantage for the regeneration process. It has been demonstrated that platelets release extracellular vesicles, which are thought to be necessary for tissue regeneration and can change the phenotype and function of recipient cells by carrying various proteins, bioactive lipids, and even genetic information through extracellular vesicles. In a study of 33 patients with thin gingival phenotype, injectable platelet-rich fibrin was applied on one side and injectable platelet-rich fibrin with microneedling on the other side, and mucosal thickness and keratinized mucosal width were compared. According to the results of the study, it was observed that mucosal thickness increased more in the group in which injectable platelet-rich fibrin was applied with the microneedling method. It was stated that microneedle application of injectable platelet-rich fibrin was less invasive and injectable platelet-rich fibrin showed good results in increasing mucosal thickness. In the literature, there are studies evaluating the application of injectable platelet-rich fibrin to the gingiva and oral mucosa around the tooth, but injectable platelet-rich fibrin application around the implant has not been encountered. To evaluate the effect of subgingival and submucosal injectable platelet-rich fibrin application on peri-implant soft tissue phenotype in patients with insufficient 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 mucosal width and mucosal thickness who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology. Systemic and dental anamnesis will be taken from the patients before the operation, clinical measurements (plaque index, gingival index, clinical attachment loss, bleeding index on probing, pocket depth, peri-implant keratinized mucosa width, peri-implant mucosa thickness, and peri-implant gingival phenotype) will be recorded, standardized photographs will be obtained from the region and pink esthetic scoring will be performed. Implants with insufficient peri-implant soft tissue phenotype will be locally anesthetized. There are two study groups according to peri-implant mucosa phenotype: Thin phenotype and thick phenotype. Before the procedure, venous blood taken from the patient will be centrifuged at 700 RPM for 3 minutes in glass tubes without addition to obtain injectable platelet-rich fibrin. Injectable platelet-rich fibrin will be taken into a 2 cc syringe. 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. Postoperatively, standardized photographs will be obtained at 1, 3, 6, and 12 months, pink esthetic scoring will be performed, and keratinized gingival height, keratinized mucosa width, mucosal thickness, and gingival phenotype will be recorded in the peri-implant site.

Being tested
Platelet rich fibrin
Keywords
Peri-implant soft tissue, Injectable platelet-rich fibrin, Platelet-rich fibrin, Phenotype

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet rich fibrinProcedure or surgery

    Also called Injectable plateler rich fibrin

    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.

Study groups in NCT06753396
Study groupRoleWhat they receive
Thin phenotypeOtherMucosa thickness is less than 1 mm and the visibility of the probe in the sulcus is high.
Receives: Procedure: Platelet rich fibrin
Thick phenotypeOtherMucosa thickness is greater than 1 mm and visibility of the probe in the sulcus is low.
Receives: Procedure: Platelet rich fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-year follow-up of all implants

  2. 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.

    Measured: 1-year follow-up of all implants

Secondary outcomes (1)
  1. Pink esthetic score

    To measure the effect of subgingival and submucosal injectable platelet-rich fibrin application on the pink aesthetic score by the patient and physician in patients with inadequate peri-implant soft tissue phenotype.

    Measured: 1-year follow-up of all implants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start15 Dec 2022
  3. Primary completion15 Dec 2025 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753396
Sponsor's protocol ID
2022-17/08
Status last verified
Sep 2025
First submitted
26 Nov 2024
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol Statistical Analysis Plan (SAP)

Publications

  • 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.

    PubMed 35607316
  • 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.

    PubMed 31912532
  • 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.

    PubMed 28154995
  • 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.

    PubMed 31576957
  • 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.

    PubMed 18548930
  • 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.

    PubMed 19719741
  • 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.

    PubMed 16881810
  • 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.

    PubMed 32710810

Questions about this trial

What is this clinical trial studying?

A study testing Platelet rich fibrin in people with Peri-Implant Tissues, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berceste Güler Ayyıldız (+05059359207, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-implant keratinized mucosa width (time frame: 1-year follow-up of all implants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06753396, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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