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
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:
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.
Altinbas University is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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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
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
İnterdental papilla will be injected by i-PRF.
Interdental papilla will be injected by Teosyal PureSense Global Action HA gel.
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
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
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
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
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
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
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
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Altinbas University