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Gingival RecessionNCT05591326

The Effect of Using Injectable Platelet-rich Fibrin on Root Surface Closure in Patients with Gingival Recession.

A study testing i-PRF application procedure in people with Gingival Recession and Gingival Recession, Localized, run by Berceste Guler at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

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

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
i-PRF application procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Sep 2021to 4 Dec 2025
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

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

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

    Kütahya, 43100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Using Injectable Platelet-rich Fibrin with Microneedling Technique on Creeping Attachment

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.

Read the detailed description

Gingival recession is the term used to describe the apical positioning of the marginal gingiva from the cemento-enamel junction. Gingival recession can cause hypersensitivity, pain, root caries, cervical erosion and/or abrasion, tooth loss, increased plaque accumulation as a result of exposure of the root surface to the oral environment, and therefore inflammation. Platelet-rich fibrin has been used routinely for more than 20 years to increase keratinized gingival thickness and close gingival recessions due to the growth factors it contains. In a study examining the effect of injectable platelet-rich fibrin (i-PRF) combined with free gingival graft (SDG) on SDG, it was shown that i-PRF has a positive effect on root surface closure. In the literature, studies to increase gingival thickness have reported that the application of i-PRF with microneedle is less invasive and i-PRF shows good results in increasing gingival thickness. The term creeping attachment is defined as the coronal positioning of the gingiva, especially after free gingival graft or connective tissue operations in the mandibular anterior region. There are various hypotheses explaining the mechanism of the creeping attachment - such as the contraction of collagen fibrils - but this issue has not been clarified yet. In some studies presented, it has been reported that the creeping attachment condition starts in the 2nd month postoperatively and can be seen even after 5 years. 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 non-smoker patients older than 18 years of age with gingival recession in mandibular anterior teeth and keratinized gingival deficiency will be included in the study. Systemic and dental anamnesis will be taken from the patient before the operation and clinical measurements will be recorded.

Periodontal indices and clinical measurements will be taken from the patients with gingival recession after Phase I treatment and oral hygiene training. The clinical periodontal measurements to be taken are as follows:

  1. Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
  2. Gingival index (Silness \& Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
  3. Attachment loss: It is the value of the distance between a tooth and the free gingiva by using a periodontal probe, based on the enamel-cementum junction.
  4. Bleeding on probing index (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
  5. Pocket depth: It is the vertical distance measured between a standard periodontal probe and the base of the periodontal sulcus and the gingival margin.
  6. Keratinized gingival height: It is the distance from the free gingival margin to the mucogingival junction line.
  7. Keratinized gingival thickness: It is the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
  8. Gingival recession depth: It is obtained by measuring the distance between the gingival margin in the midbuccal region and the enamel-cementum junction.
  9. Gingival recession width: It is the amount of mesio-distal width of recession from the midpoint of the distance between the enamel cement junction and the gingival margin.
  10. Keratinized mucosa thickness: After local anesthesia, it is measured with a periodontal probe or with the help of a spreader and rubber stopper.
  11. Gingival phenotype: Visibility of the periodontal probe in the sulcus
  12. Vestibular sulcus depth: It is the distance measured from the gingival margin to the base of the sulcus.

Obtaining Standardized Photographs Photographs of the region will be taken to measure the keratinized gingival width and gingival recession. The camera lens will be set perpendicular to the area when taking pictures. In order to determine the measurements in millimeters and to standardize the measurements on the photographs, 4.0 mm long rods of 1 mm thick round wire will be prepared. Photos will be taken in this way by placing it on the soft tissue close to the operation area. In order to standardize photographic images, images will be obtained with the same camera using the same standard magnification size.

Surgical Operation

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.

Sample Selection: When the effect size was taken as 0.06 for the significance value in the G Power analysis program, it was planned to take 50 teeth for α= 0.05 and 80% power.

Statistical analysis method:

Gingival phenotypes will be divided into two groups as thin and thick. All analyzes will be done with the SPSS software program. Intra-temporal evaluations between the two groups will be evaluated using the Paired sample -T or Wilcoxon test according to the normal distribution values. According to the normal distribution of the data for intergroup comparisons, the Student-t test will be analyzed for parametric in-group evaluations and the Mann Withney U test for nonparametrics. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.

Being tested
i-PRF application procedure
Keywords
i-PRF, creeping attachment, Keratinized gingival thickness, Gingival Recession
Medical subject headings
Gingival Recession

What participants receive

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

  • i-PRF application procedureProcedure or surgery

    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.

Study groups in NCT05591326
Study groupRoleWhat they receive
Cases in RT1 class according to gingival recession depthExperimentalDepth of gingival recession in mandibular anterior teeth, according to the 2017 Periodontal Classification, cases in RT1 class will be included.
Receives: Procedure: i-PRF application procedure

What is being measured

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

  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.

    Measured: 1 year

Timeline

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

  1. First posted24 Oct 2022
  2. Study start6 Sep 2021
  3. Primary completion5 Sep 2025 (estimated)
  4. Study completion4 Dec 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591326
Sponsor's protocol ID
2020-04/02
Status last verified
Mar 2025
First submitted
19 Oct 2022
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared in case of contacting the research coordinator.

Publications

  • 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.

    PubMed 32896991
  • 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.

    PubMed 6610486
  • 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.

    PubMed 32591868
  • Ayyildiz BG, Terzioglu B, Eken S. Comparison of root coverage by injectable-platelet rich fibrin in thick and thin phenotypes: a parallel-armed, prospective, preliminary clinical study with up to 48 months of follow-up. J Appl Oral Sci. 2026 Apr 17;34:e20250702. doi: 10.1590/1678-7765-2025-0702. eCollection 2026.

    PubMed 42018795

Questions about this trial

What is this clinical trial studying?

A study testing i-PRF application procedure in people with Gingival Recession and Gingival Recession, Localized, run by Berceste Guler 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 8 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 10 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The amount of root closure will be measured with the creeping attachment. (time frame: 1 year). 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 NCT05591326, which also lists 4 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 10 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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