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CompletedNCT06314256Updated Dec 8, 2025

Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction

A Phase 4 interventional study of I-PRF Injection and Teosyal PureSense Global Action HA Injection in Interdental Papilla Loss, sponsored by Altinbas University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Altinbas University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are:

  • How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss?
  • Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last.
Read the detailed description

Nowadays, individuals give great importance to their appearance and dental aesthetics plays a key role in their personal appearance. Dental aesthetics is a combination of white and pink aesthetics formed by teeth and gums. The part of the gingival tissue that fills the triangular shaped spaces between the teeth is the interdental papilla. The presence of papillae in the teeth is closely related to the distance between the contact point between the teeth and the alveolar bone crest. Periodontal diseases, traumatic oral hygiene practices, incorrect orthodontic forces, incompatible restoration contour, the presence of diastema as a result of neighbouring teeth not being in contact, and tooth loss can cause loss of interdental papillae, resulting in the formation of gaps called black triangles. In addition to aesthetic problems, loss of interdental papillae can cause speech difficulties and food impaction.

Interdental papilla loss is one of the most important aesthetic periodontal difficulties and at the same time one of the most difficult problems to treat. Various surgical methods and flap designs have been proposed for the treatment and reconstruction of interdental papillae. However, current surgical methods have limited success and lack predictability, especially because the gingival papilla has a sensitive structure and less blood supply compared to other parts of the gingiva. Therefore, non-surgical methods have gained importance. As a result of the development of tissue engineering, dermal filling materials have started to be produced in recent years. Among these materials, hyaluronic acid (HA) is one of the basic components of connective tissue and especially its water binding/retention property makes it a determinant of tissue volume. HA enables the migration of fibroblast cells involved in collagen production and also acts as a liquid matrix where collagen and elastic fibres will proliferate. Due to these properties, Becker et al. first demonstrated in 2010 that it was possible to reconstruct a small area of interdental papilla loss in a minimally invasive and predictable manner using injectable HA gel. Subsequently, HA injections in interdental papil reconstructions have frequently been successfully reported in the literature.

Platelet Rich Fibrin (PRF) is an autologous, membrane-form product prepared by centrifugation of the patient's own blood. This fibrin matrix containing platelets, leukocytes and various growth factors is used especially in regenerative periodontal surgical operations. Injectable PRF (i-PRF), obtained by modifying the preparation protocol, forms a dynamic hydrogel by increasing the number of cells and releasing growth factors more frequently. I-PRF serves as a source of slow-release growth factors that help remodelling of the interdental papilla. Using data obtained through standardised photographs, the project will evaluate the effectiveness of area closure rates of black triangles caused by papilla loss over a 3-month period and measure patient feedback and satisfaction.

02

Conditions studied

  • Interdental Papilla Loss

Keywords

  • interdental papilla loss
  • black triangle
  • interdental papilla reconstruction
  • hyaluronic acid
  • injectable platelet rich fibrin
03

In context

Lead sponsor

Altinbas University is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Systemically healthy (without cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases)
  • Patients with PPI 2 and PPI 3 papillae according to the Papillary Presence Index classification
  • Probable pocket depth of 4 mm or less in the relevant area
  • Plaque index and gingival index in the range of 0-1
  • Neighbouring teeth in contact with each other in the relevant area
  • Absence of any restoration in the relevant area
  • Non-smoker
  • No surgical periodontal treatment in the last 6 months
  • For female subjects not pregnant or lactating
  • No known allergy to hyaluronic acid

Exclusion criteria

Exclusion Criteria:

  • Not systemically healthy (with cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases)
  • Diagnosed with periodontitis
  • History of allergic reactions to hyaluronic acid
  • Less than 2 mm keratinized tissue height in the relevant area
  • Teeth crowding in relevant area
  • Any kind of restoration (fillings, crowns, etc.) in the relevant area
  • Smoker
  • Ongoing orthodontic treatment
  • Having parafunctional habits (bruxism, etc.)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    Injectable PRF

    i-PRF is produced by cenrifugation of patients own blood. Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

    Biological: I-PRF Injection · Drug: Teosyal PureSense Global Action HA Injection

  • Active comparator
    Hyaluronic Acid

    Teosyal® Global Action PureSense. Composition: Cross-linked hyaluronic acid (HA): 25 mg/ml Lidocaine; 0,3%, (injection). Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

    Biological: I-PRF Injection · Drug: Teosyal PureSense Global Action HA Injection

Interventions

  • BiologicalI-PRF Injection

    İnterdental papilla will be injected by i-PRF.

  • DrugTeosyal PureSense Global Action HA Injection

    Interdental papilla will be injected by Teosyal PureSense Global Action HA gel.

06

What researchers measure

Primary outcomes

  1. Black Triangle Area

    Using standardized intraoral photographs, change in black triangle area in mm² will be measured

    Time frame: After the last injection: 1 month - 3 months

  2. Intedental Papilla Reconstruction Rate

    Changes in Black Triangle Area given in percentage to the baseline values

    Time frame: After the last injection: 1 month - 3 months

Secondary outcomes

  1. Patient Satisfaction Score

    Patient satisfaction of each treatment option will be measured using Visual Analog Score (VAS).

    Time frame: After the last injection: 3 months

  2. Black Triangle Width

    Using standardized intraoral photographs, change in black triangle width in mm will be measured

    Time frame: After the last injection: 1 month - 3 months

  3. Black Triangle Height

    Using standardized intraoral photographs, change in black triangle height in mm will be measured

    Time frame: After the last injection: 1 month - 3 months

Other outcomes

  1. Correlation between Interdental Papilla Reconstruction Rate and Interdental Bone Crest-Interproximal Contact Point Distance

    Correlation between Interdental Papilla Reconstruction Rate(%) and Interdental Bone Crest-Interproximal Contact Point Distance(mm)

    Time frame: After the last Injection: 1 month-3 months

  2. Correlation between Interdental Papilla Reconstruction Rate and Keratinised Tissue Thickness

    Correlation between Interdental Papilla Reconstruction Rate(%) and Keratinised Tissue Thickness(mm)

    Time frame: After the last Injection: 1 month-3 months

07

Study locations

1 site
  • Altinbas University
    Istanbul, Turkey (Türkiye)
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 14, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06314256
Lead sponsor
Altinbas University
Responsible party
Baris Impram (Principal Investigator, Altinbas University) — Principal investigator
First posted
Mar 18, 2024
Start date
Apr 10, 2024
Primary completion
Jun 1, 2025
Completion
Jun 25, 2025
Last update
Dec 8, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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