Interdental Papilla LossPhase 4NCT06314256
Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction
A Phase 4 study testing I-PRF Injection and Teosyal PureSense Global Action HA Injection in people with Interdental Papilla Loss, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interdental Papilla Loss
- What is being tested?
- I-PRF Injection and Teosyal PureSense Global Action HA Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 25 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Non-smoker
- No surgical periodontal treatment in the last 6 months
- For female subjects not pregnant or lactating
- No known allergy to hyaluronic acid
Who cannot join
- 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
Show all 9Show fewer
- Smoker
- Ongoing orthodontic treatment
- Having parafunctional habits (bruxism, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Interdental Papilla Loss
- Being tested
- I-PRF Injection, Teosyal PureSense Global Action HA Injection
- Keywords
- interdental papilla loss, black triangle, interdental papilla reconstruction, hyaluronic acid, injectable platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PRF InjectionBiological
İnterdental papilla will be injected by i-PRF.
Teosyal PureSense Global Action HA InjectionDrug
Interdental papilla will be injected by Teosyal PureSense Global Action HA gel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: I-PRF Injection; Drug: Teosyal PureSense Global Action HA Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Black Triangle Area
Using standardized intraoral photographs, change in black triangle area in mm² will be measured
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
Measured: After the last injection: 1 month - 3 months
Secondary outcomes (3)
Patient Satisfaction Score
Patient satisfaction of each treatment option will be measured using Visual Analog Score (VAS).
Measured: After the last injection: 3 months
Black Triangle Width
Using standardized intraoral photographs, change in black triangle width in mm will be measured
Measured: 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
Measured: After the last injection: 1 month - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 Apr 2024
- Primary completion1 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papilla LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Impram, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314256
- Sponsor's protocol ID
- 2023/218
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction
- ClinicalTrials.gov ID
- NCT06314256
- Acronym / sponsor ID
- 2023/218
- Conditions
- Interdental Papilla Loss
- Keywords
- interdental papilla loss, black triangle, interdental papilla reconstruction, hyaluronic acid, injectable platelet rich fibrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Injectable PRF | Active comparator | Biological: I-PRF Injection, Drug: Teosyal PureSense Global Action HA Injectioni-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. |
| Hyaluronic Acid | Active comparator | Biological: I-PRF Injection, Drug: Teosyal PureSense Global Action HA InjectionTeosyal® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PRF Injectionİnterdental papilla will be injected by i-PRF. | Biological | Hyaluronic Acid, Injectable PRF |
| Teosyal PureSense Global Action HA InjectionInterdental papilla will be injected by Teosyal PureSense Global Action HA gel. | Drug | Hyaluronic Acid, Injectable PRF |
Primary outcome
Black Triangle Area
Time frame: After the last injection: 1 month - 3 months
Using standardized intraoral photographs, change in black triangle area in mm² will be measured
Intedental Papilla Reconstruction Rate
Time frame: After the last injection: 1 month - 3 months
Changes in Black Triangle Area given in percentage to the baseline values
3 secondary outcomes
Patient Satisfaction Score
Time frame: After the last injection: 3 months
Black Triangle Width
Time frame: After the last injection: 1 month - 3 months
Black Triangle Height
Time frame: After the last injection: 1 month - 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Interdental Papilla Loss
Not yet recruiting
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing I-PRF Injection and Teosyal PureSense Global Action HA Injection in people with Interdental Papilla Loss, run by Altinbas 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 8 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Black Triangle Area (time frame: After the last injection: 1 month - 3 months). 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?
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 8 Dec 2025.