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

NCT06314256 | Completed Phase 4

• 1 other identifier: 2023/218
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interdental Papilla Loss

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Black Triangle Area

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

  After the last injection: 1 month - 3 months

• Intedental Papilla Reconstruction Rate

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

  After the last injection: 1 month - 3 months

Secondary Outcomes (3)

• Patient Satisfaction Score

  After the last injection: 3 months

• Black Triangle Width

  After the last injection: 1 month - 3 months

• Black Triangle Height

  After the last injection: 1 month - 3 months

Other Outcomes (2)

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

  After the last Injection: 1 month-3 months

• Correlation between Interdental Papilla Reconstruction Rate and Keratinised Tissue Thickness

  After the last Injection: 1 month-3 months

Study Arms (2)

Injectable PRF

ACTIVE COMPARATOR

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

Hyaluronic Acid

ACTIVE COMPARATOR

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

I-PRF Injection BIOLOGICAL

İnterdental papilla will be injected by i-PRF.

Hyaluronic Acid; Injectable PRF

Teosyal PureSense Global Action HA Injection DRUG

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

Hyaluronic Acid; Injectable PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be masked, which side of her/his mouth will be treated with either i-PRF or HA. The outcome assessor is blinded to the treatment modalities.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A type of study used frequently in oral research: the mouth is divided into two or more subunits. Active and control (comparison) treatments are applied to the subunits (e.g., to the left and right sides).

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: April 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 25, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

TU (1)