Interdental Papilla ReconstructionPhase 2A case seriesNCT06842277
Treatment of Deficient Interdental Papilla Using Albumin-platelets Rich Fibrin
A Phase 2 study testing Injectable albumin platelets rich fibrin in people with Interdental Papilla Reconstruction and Deficient Interdental Papilla, run by Cairo University at 2 sites in Egypt.
Trial summary
The goal of this ( A case series, clinical trial ) is treatment of deficient interdental papilla in patients who have interdental papillary loss class 1 or 2 in maxillary or mandibular anterior region with plaque index and gingival index less than 1 and the selected sites had distance between contact point and inter… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interdental Papilla Reconstruction, Deficient Interdental Papilla
- What is being tested?
- Injectable albumin platelets rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Feb 2025to 30 May 2026
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients' complaint from poor esthetics and unappealing black triangles in anterior sextant.
- Patients had well -aligned maxillary teeth, no caries, no proximal restoration, fixed prosthesis, or any orthodontic appliance.
- Patients had at least one class 1or 2 interdental papilla loss in maxillary or mandibular anterior regions.
- Patients had at selected sites, distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
- Patients had plaque index and gingival index less than 1.
Who cannot join
- Patient had advanced periodontal problems (advanced bone and soft tissue loss).
- Patients had a systemic condition affect blood components and healing.
- Smoker patients.
- Patients who are pregnant.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry , Cairo University
Giza, Giza Governorate, 12613
Faculty of Dentistry Cairo University
Giza, Giza Governorate, 12613
About this study
Official title: Reconstruction of Deficient Interdental Papilla Using Albumin-platelets Rich Fibrin- A Case Series
The goal of this ( A case series, clinical trial ) is treatment of deficient interdental papilla in patients who have interdental papillary loss class 1 or 2 in maxillary or mandibular anterior region with plaque index and gingival index less than 1 and the selected sites had distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
Hypothesis:
Albumin-PRF is an efficient treatment of deficient interdental papilla. The primary outcome ( distance between the contact point and papillary tip will be measured by periodontal probe) The participants will practice good oral hygiene measures
Read the detailed description
The goal of this ( A case series , clinical trial ) treating patients whose complaint from poor esthetics and unappealing black triangles inn anterior sextant using an autogenous , biocompatible material ( Albumin platelets rich fibrin).
The selected patients had well -aligned maxillary teeth, no caries, no proximal restoration, fixed prosthesis, or any orthodontic appliance, at least one class 1or 2 interdental papilla loss in maxillary or mandibular anterior regions and at selected sites, distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
Also patients had plaque index and gingival index less than 1. Patients whose had advanced periodontal problems (advanced bone and soft tissue loss), a systemic condition affect blood components and healing, smokers and Patients who are pregnant will be excluded.
For all patients, full mouth scaling and root planing will be done, measuring probing depth, taking periapical radiograph for the target sites and taking rubber base impression will be done.
Operation phase:
Then preparation of injectable Alb-PRF, 10ml of intravenous blood will be withdrawn from antecubital region and will be centrifuged using plastic tubes at 700g for 8 minutes. The denaturated albumin will be obtained by tempering the platelet poor plasma layer for 10 minutes at 75 degrees Celsius then the residual cells and the growth factors detected in the buffy coat (liquid PRF) will be mixed again with the cooled albumin gel to form injectable albumin PRF. Obtained injectable Alb-PRF will be filled in the insulin syringes to use in the selected sites immediately after anesthesia. The needle of the insulin syringe will be inserted 2-3 mm apical to the papilla tip directed coronally making an angle of 45 degree to the long axis of the tooth with its bevel facing apically.
Post-injection, papilla will be gently massaged in an incisal direction, for a minute using a gauze.
Post-operative phase:
Patients will be instructed to use a soft toothbrush coronal to the gingival margin and prevent the use of interdental aids at the treated region.
Patients will be kept under follow up at 3 and 6 months wherein clinical and photographic parameters will be recorded.
Primary outcome:
Distance between contact point and papilla tip (Height of black triangle)
Secondary outcomes:
Surface area of black triangle Patient Satisfaction Interproximal papillary levels
- Being tested
- Injectable albumin platelets rich fibrin
- Keywords
- Reconstruction of deficient interdental papilla using injectable albumin platelets rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable albumin platelets rich fibrinBiological
Using injectable albumin platelets rich fibrin which is minimally invasive non surgical technique with autogenous , slow degradable and rich in leukocytes and growth factors material .
| Study group | Role | What they receive |
|---|---|---|
| patients whose had deficient interdental papilla | Other | treatment of patients whose had deficient interdental papilla using injectable Albumin -platelets rich fibrin Receives: Biological: Injectable albumin platelets rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between contact point and papilla tip (Height of black triangle)
The distances between the contact point and papilla tip will be measured clinically by a periodontal probe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start18 Feb 2025
- Primary completion30 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papilla ReconstructionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A case series
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Salah Eldin Mahmoud Radwan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842277
- Sponsor's protocol ID
- 20124
- Acronym
- A case series
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Deficient Interdental Papilla Using Albumin-platelets Rich Fibrin- A Case Series
- ClinicalTrials.gov ID
- NCT06842277
- Acronym / sponsor ID
- A case series / 20124
- Keywords
- Reconstruction of deficient interdental papilla using injectable albumin platelets rich fibrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 24 Feb 2025 (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 ( A case series, clinical trial ) is treatment of deficient interdental papilla in patients who have interdental papillary loss class 1 or 2 in maxillary or mandibular anterior region with plaque index and gingival index less than 1 and the selected sites had distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
Hypothesis:
Albumin-PRF is an efficient treatment of deficient interdental papilla. The primary outcome ( distance between the contact point and papillary tip will be measured by periodontal probe) The participants will practice good oral hygiene measures
Detailed description
The goal of this ( A case series , clinical trial ) treating patients whose complaint from poor esthetics and unappealing black triangles inn anterior sextant using an autogenous , biocompatible material ( Albumin platelets rich fibrin).
The selected patients had well -aligned maxillary teeth, no caries, no proximal restoration, fixed prosthesis, or any orthodontic appliance, at least one class 1or 2 interdental papilla loss in maxillary or mandibular anterior regions and at selected sites, distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
Also patients had plaque index and gingival index less than 1. Patients whose had advanced periodontal problems (advanced bone and soft tissue loss), a systemic condition affect blood components and healing, smokers and Patients who are pregnant will be excluded.
For all patients, full mouth scaling and root planing will be done, measuring probing depth, taking periapical radiograph for the target sites and taking rubber base impression will be done.
Operation phase:
Then preparation of injectable Alb-PRF, 10ml of intravenous blood will be withdrawn from antecubital region and will be centrifuged using plastic tubes at 700g for 8 minutes. The denaturated albumin will be obtained by tempering the platelet poor plasma layer for 10 minutes at 75 degrees Celsius then the residual cells and the growth factors detected in the buffy coat (liquid PRF) will be mixed again with the cooled albumin gel to form injectable albumin PRF. Obtained injectable Alb-PRF will be filled in the insulin syringes to use in the selected sites immediately after anesthesia. The needle of the insulin syringe will be inserted 2-3 mm apical to the papilla tip directed coronally making an angle of 45 degree to the long axis of the tooth with its bevel facing apically.
Post-injection, papilla will be gently massaged in an incisal direction, for a minute using a gauze.
Post-operative phase:
Patients will be instructed to use a soft toothbrush coronal to the gingival margin and prevent the use of interdental aids at the treated region.
Patients will be kept under follow up at 3 and 6 months wherein clinical and photographic parameters will be recorded.
Primary outcome:
Distance between contact point and papilla tip (Height of black triangle)
Secondary outcomes:
Surface area of black triangle Patient Satisfaction Interproximal papillary levels
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A case series
| Arm | Type | Receives |
|---|---|---|
| patients whose had deficient interdental papilla | Other | Biological: Injectable albumin platelets rich fibrintreatment of patients whose had deficient interdental papilla using injectable Albumin -platelets rich fibrin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients' complaint from poor esthetics and unappealing black triangles in anterior sextant.
- Patients had well -aligned maxillary teeth, no caries, no proximal restoration, fixed prosthesis, or any orthodontic appliance.
- Patients had at least one class 1or 2 interdental papilla loss in maxillary or mandibular anterior regions.
- Patients had at selected sites, distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
- Patients had plaque index and gingival index less than 1.
Key exclusion criteria (4 listed)
- Patient had advanced periodontal problems (advanced bone and soft tissue loss).
- Patients had a systemic condition affect blood components and healing.
- Smoker patients.
- Patients who are pregnant.
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 |
|---|---|---|
| Injectable albumin platelets rich fibrinUsing injectable albumin platelets rich fibrin which is minimally invasive non surgical technique with autogenous , slow degradable and rich in leukocytes and growth factors material . | Biological | patients whose had deficient interdental papilla |
Primary outcome
Distance between contact point and papilla tip (Height of black triangle)
Time frame: 6 months
The distances between the contact point and papilla tip will be measured clinically by a periodontal probe
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 24 Jul 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injectable albumin platelets rich fibrin in people with Interdental Papilla Reconstruction and Deficient Interdental Papilla, run by Cairo University at 2 sites in Egypt.
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 5 inclusion and 4 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Distance between contact point and papilla tip (Height of black triangle) (time frame: 6 months). 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 24 Jul 2026.