Papilla ReconstructionPhase 3ALB-PRF & CTGNCT07139392
A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla
A Phase 3 study testing Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft in people with Papilla Reconstruction, run by shaimaa hamdy.
Trial summary
The interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient's smile but also lead to challenges such as… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Papilla Reconstruction
- What is being tested?
- Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 23 Sep 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-55 years
- Nordland and Tarnow Class I/II papillary loss
- Good oral hygiene (FMPS \& FMBS <20%)
- Systemically healthy
Who cannot join
- Smoking
- Periodontal pockets >4 mm in the target site
- History of systemic diseases or medications affecting healing
- Pregnant or lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
shaimaa Hamdy, lecturer of Periodontology contact
About this study
The interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient's smile but also lead to challenges such as food impaction, phonetic difficulties, and increased risk of periodontal disease. The reconstruction of the interdental papilla is recognized as one of the most challenging procedures in periodontal therapy, particularly when aiming for enhanced esthetic outcomes and patient satisfaction
Read the detailed description
Connective tissue grafts (CTG) have traditionally been regarded as the gold standard for papilla reconstruction due to their predictable augmentation of soft tissues and stable long-term results. However, CTG procedures are invasive, requiring tissue harvesting from a donor site (often the palate), and are associated with increased surgical morbidity and discomfort for patients.
Advances in regenerative medicine have introduced minimally invasive alternatives, such as injectable biologically active platelet-rich fibrin (Bio-PRF). Bio-PRF is an autologous platelet concentrate containing a high concentration of growth factors, fibrin matrix, and immunomodulatory cells. The injectable form is designed to be applied directly into tissue-deficient papillary sites, promoting enhanced angiogenesis, cell proliferation, and tissue regeneration with minimal trauma and improved patient comfort.
Recent clinical interest has focused on comparing these two approaches, CTG and injectable Bio-PRF, in their efficacy for papilla regeneration. While both techniques have demonstrated potential benefits, direct comparative studies are limited. Understanding the relative effectiveness, esthetic outcomes, surgical morbidity, and patient-centered results of these interventions is essential for evidence-based clinical decision making.
This clinical comparison seeks to evaluate and contrast the outcomes of connective tissue grafting and injectable Bio-PRF in the reconstruction of lost or compromised interdental papillae. The study aims to provide valuable insights into the optimal management of papillary defects, guiding periodontal practitioners toward treatments that maximize esthetic and functional results while minimizing patient morbidity.
We hypothesized that no significant difference between the treatment of interdental papilla with connective tissue graft or Bio-PRF.
Aim of the study
Primary Objective:
To assess the effectiveness of CTG combined with Bio-PRF in increasing papillary height in patients with papillary loss (Nordland and Tarnow Class I or II).
Secondary Objectives:
- To evaluate changes in patient satisfaction and aesthetic outcomes.
- To assess soft tissue healing and clinical attachment gain.
Materials and methods:
Study Design:
- Type: Randomized Controlled Clinical Trial
- Duration: 6 months follow-up
- Groups:
- Group A (control): CTG alone
- Group B (study): injectable Bio-PRF
Sample Selection:
- Inclusion Criteria:
- Age 20-55 years
- Nordland and Tarnow Class I/II papillary loss
- Good oral hygiene (FMPS \& FMBS <20%)
- Systemically healthy
- Exclusion Criteria:
- Smoking
- Periodontal pockets >4 mm in target site
- History of systemic diseases or medications affecting healing
- Pregnant or lactating women
- Preoperative Phase:
- Oral hygiene instruction
- Phase I periodontal therapy
- Initial photography and papillary height measurements using digital calipers or customized stents
- Surgical Technique:
- Local anesthesia
- Intrasulcular incision around target teeth
- Papilla preservation flap
- Harvesting CTG from the palate
- Injection of liquid Bio-PRF at the papillary base (test group)
- CTG positioned in the papilla region
- Suturing with microsurgical technique
- Postoperative Protocol:
- Analgesics (e.g., ibuprofen 400 mg)
- Chlorhexidine 0.12% mouth rinse for 2 weeks
- Suture removal at 10-14 days
- Follow-up at 1 month, 3 months, and 6 months
Outcome Measures:
- Primary Outcome:
- Papilla Height Gain (measured from contact point to papilla tip)
- Secondary Outcomes:
- Visual Analog Scale (VAS) for aesthetic satisfaction
- Healing Index
- Black triangle area (measured via intraoral photographs or digital scanning)
Statistical Analysis:
- Descriptive statistics for baseline data
- Paired t-test or Wilcoxon signed-rank test (intragroup comparison)
- Independent t-test or Mann-Whitney U test (intergroup comparison)
- p-value < 0.05 considered statistically significant
- Conditions
- Papilla Reconstruction
- Being tested
- Albumin (5% serum-protein solution containing immunoglobulins), connective tissue graft
- Keywords
- ALB-PRF, papilla, connective tissue, reconstruction, MINST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin (5% serum-protein solution containing immunoglobulins)Biological
Also called alb-prf
- Preoperative Phase:
- Oral hygiene instruction
- Phase I periodontal therapy
- Initial photography and papillary height measurements using digital calipers or customized stents
- Surgical Technique:
- Local anesthesia
- Intrasulcular incision around target teeth
- Papilla preservation flap
- Harvesting CTG from the palate
- Injection of liquid Bio-PRF at the papillary base (test group)
- CTG positioned in the papilla region
- Suturing with microsurgical technique
- Postoperative Protocol:
- Analgesics (e.g., ibuprofen 400 mg)
- Chlorhexidine 0.12% mouth rinse for 2 weeks
- Suture removal at 10-14 days
- Follow-up at 1 month, 3 months, and 6 months
connective tissue graftBiological
Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft | Placebo comparator | Semi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction Receives: Biological: connective tissue graft |
| albumin-PRF | Active comparator | Albumin- PRF for papilla reconstruction Receives: Biological: Albumin (5% serum-protein solution containing immunoglobulins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilla Height Gain
Papilla Height Gain (measured from contact point to papilla tip)
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion23 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilla ReconstructionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sample Selection: * Inclusion Criteria: * Age 20-55 years * Nordland and Tarnow Class I/II papillary loss * Good oral hygiene (FMPS \& FMBS \<20%) * Systemically healthy * Exclusion Criteria: * Smoking * Periodontal pockets \>4 mm in target site * History of systemic diseases or medications affecting healing * Pregnant or lactating women * Preoperative Phase: * Oral hygiene instruction * Phase I periodontal therapy * Initial photography and papillary height measurements using digital calipers or customized stents * Surgical Technique: * Local anesthesia * Intrasulcular incision around target teeth * Papilla preservation flap * Harvesting CTG from the palate * Injection of liquid Bio-PRF at the papillary base (test group) * CTG positioned in the papilla region * Suturing with microsurgical technique * Postoperative Protocol: * Analgesics (e.g., ibuprofen 400 mg) * Chlorhexidine 0.12% mouth rinse for 2 weeks * Suture removal at 10-14 days * Follow-up
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- shaimaa hamdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shaimaa hamdy, Minia University
- Investigators
- shaimaa Hamdy, lecturer, Principal investigator, lecturer of periodontology Nahda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139392
- Sponsor's protocol ID
- ALB -PRF in papilla
- Other IDs
- committee 1165
- Acronym
- ALB-PRF & CTG
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completing the study, I will share all the data of the study
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla
- ClinicalTrials.gov ID
- NCT07139392
- Acronym / sponsor ID
- ALB-PRF & CTG / ALB -PRF in papilla
- Conditions
- Papilla Reconstruction
- Keywords
- ALB-PRF, papilla, connective tissue, reconstruction, MINST
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- shaimaa hamdyUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 23 Sep 2025 (estimated)
- First posted
- 24 Aug 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 interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient's smile but also lead to challenges such as food impaction, phonetic difficulties, and increased risk of periodontal disease. The reconstruction of the interdental papilla is recognized as one of the most challenging procedures in periodontal therapy, particularly when aiming for enhanced esthetic outcomes and patient satisfaction
Detailed description
Connective tissue grafts (CTG) have traditionally been regarded as the gold standard for papilla reconstruction due to their predictable augmentation of soft tissues and stable long-term results. However, CTG procedures are invasive, requiring tissue harvesting from a donor site (often the palate), and are associated with increased surgical morbidity and discomfort for patients.
Advances in regenerative medicine have introduced minimally invasive alternatives, such as injectable biologically active platelet-rich fibrin (Bio-PRF). Bio-PRF is an autologous platelet concentrate containing a high concentration of growth factors, fibrin matrix, and immunomodulatory cells. The injectable form is designed to be applied directly into tissue-deficient papillary sites, promoting enhanced angiogenesis, cell proliferation, and tissue regeneration with minimal trauma and improved patient comfort.
Recent clinical interest has focused on comparing these two approaches, CTG and injectable Bio-PRF, in their efficacy for papilla regeneration. While both techniques have demonstrated potential benefits, direct comparative studies are limited. Understanding the relative effectiveness, esthetic outcomes, surgical morbidity, and patient-centered results of these interventions is essential for evidence-based clinical decision making.
This clinical comparison seeks to evaluate and contrast the outcomes of connective tissue grafting and injectable Bio-PRF in the reconstruction of lost or compromised interdental papillae. The study aims to provide valuable insights into the optimal management of papillary defects, guiding periodontal practitioners toward treatments that maximize esthetic and functional results while minimizing patient morbidity.
We hypothesized that no significant difference between the treatment of interdental papilla with connective tissue graft or Bio-PRF.
Aim of the study
Primary Objective:
To assess the effectiveness of CTG combined with Bio-PRF in increasing papillary height in patients with papillary loss (Nordland and Tarnow Class I or II).
Secondary Objectives:
- To evaluate changes in patient satisfaction and aesthetic outcomes.
- To assess soft tissue healing and clinical attachment gain.
Materials and methods:
Study Design:
- Type: Randomized Controlled Clinical Trial
- Duration: 6 months follow-up
- Groups:
- Group A (control): CTG alone
- Group B (study): injectable Bio-PRF
Sample Selection:
- Inclusion Criteria:
- Age 20-55 years
- Nordland and Tarnow Class I/II papillary loss
- Good oral hygiene (FMPS \& FMBS <20%)
- Systemically healthy
- Exclusion Criteria:
- Smoking
- Periodontal pockets >4 mm in target site
- History of systemic diseases or medications affecting healing
- Pregnant or lactating women
- Preoperative Phase:
- Oral hygiene instruction
- Phase I periodontal therapy
- Initial photography and papillary height measurements using digital calipers or customized stents
- Surgical Technique:
- Local anesthesia
- Intrasulcular incision around target teeth
- Papilla preservation flap
- Harvesting CTG from the palate
- Injection of liquid Bio-PRF at the papillary base (test group)
- CTG positioned in the papilla region
- Suturing with microsurgical technique
- Postoperative Protocol:
- Analgesics (e.g., ibuprofen 400 mg)
- Chlorhexidine 0.12% mouth rinse for 2 weeks
- Suture removal at 10-14 days
- Follow-up at 1 month, 3 months, and 6 months
Outcome Measures:
- Primary Outcome:
- Papilla Height Gain (measured from contact point to papilla tip)
- Secondary Outcomes:
- Visual Analog Scale (VAS) for aesthetic satisfaction
- Healing Index
- Black triangle area (measured via intraoral photographs or digital scanning)
Statistical Analysis:
- Descriptive statistics for baseline data
- Paired t-test or Wilcoxon signed-rank test (intragroup comparison)
- Independent t-test or Mann-Whitney U test (intergroup comparison)
- p-value < 0.05 considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sample Selection: * Inclusion Criteria: * Age 20-55 years * Nordland and Tarnow Class I/II papillary loss * Good oral hygiene (FMPS \& FMBS <20%) * Systemically healthy * Exclusion Criteria: * Smoking * Periodontal pockets >4 mm in target site * History of systemic diseases or medications affecting healing * Pregnant or lactating women * Preoperative Phase: * Oral hygiene instruction * Phase I periodontal therapy * Initial photography and papillary height measurements using digital calipers or customized stents * Surgical Technique: * Local anesthesia * Intrasulcular incision around target teeth * Papilla preservation flap * Harvesting CTG from the palate * Injection of liquid Bio-PRF at the papillary base (test group) * CTG positioned in the papilla region * Suturing with microsurgical technique * Postoperative Protocol: * Analgesics (e.g., ibuprofen 400 mg) * Chlorhexidine 0.12% mouth rinse for 2 weeks * Suture removal at 10-14 days * Follow-up
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft | Placebo comparator | Biological: connective tissue graftSemi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction |
| albumin-PRF | Active comparator | Biological: Albumin (5% serum-protein solution containing immunoglobulins)Albumin- PRF for papilla reconstruction |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-55 years
- Nordland and Tarnow Class I/II papillary loss
- Good oral hygiene (FMPS \& FMBS <20%)
- Systemically healthy
Key exclusion criteria (4 listed)
- Smoking
- Periodontal pockets >4 mm in the target site
- History of systemic diseases or medications affecting healing
- Pregnant or lactating women
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 |
|---|---|---|
| Albumin (5% serum-protein solution containing immunoglobulins)Also: alb-prf* Preoperative Phase: * Oral hygiene instruction * Phase I periodontal therapy * Initial photography and papillary height measurements using digital calipers or customized stents * Surgical Technique: * Local anesthesia * Intrasulcular incision around target teeth * Papilla preservation flap * Harvesting CTG from the palate * Injection of liquid Bio-PRF at the papillary base (test group) * CTG positioned in the papilla region * Suturing with microsurgical technique * Postoperative Protocol: * Analgesics (e.g., ibuprofen 400 mg) * Chlorhexidine 0.12% mouth rinse for 2 weeks * Suture removal at 10-14 days * Follow-up at 1 month, 3 months, and 6 months | Biological | albumin-PRF |
| connective tissue graftLocal anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate | Biological | connective tissue graft |
Primary outcome
Papilla Height Gain
Time frame: 6 months follow up
Papilla Height Gain (measured from contact point to papilla tip)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Modified interproximal tunneling technique with customized sub-epithelial connective tissue graft for gingival papilla reconstruction: report of three cases with a cutback incision on the palatal sideLink provided by the sponsor.
- Individual participant dataSharing planned: No. After completing the study, I will share all the data of the study
Related trials for Papilla Reconstruction
Not yet recruiting
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
Not yet recruitingPhase 3
Comparative Evaluation of Alb PRF Versus Connective Tissue Graft in Reconstruction of Deficient Interdental Papilla
Deficient Interdental Papilla
Recruiting
Clinical Evaluation of Different Treatments for Interdental Black Triangles
Black Triangles Syndrome (BTS), Papilla Reconstruction
Active, not recruitingEarly Phase 1
Comparing Microneedling and Injectable Platelet Rich Fibrin to Hyaluronic Acid In Papilla Reconstruction
Papilla Reconstruction
Recruiting
Three Types of Papilla Incision in Periodontal Surgery
Periodontitis, Periodontal Diseases
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.
shaimaa Hamdy, lecturer of Periodontology contact
shaimaa Hamdy, lecturer principal investigator
lecturer of periodontology Nahda University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft in people with Papilla Reconstruction, run by shaimaa hamdy.
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 4 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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa Hamdy, lecturer of Periodontology (+201030576405 ext. +201555035523, shimaa.3m.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Papilla Height Gain (time frame: 6 months follow up). 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 Aug 2025.