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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

+201030576405 ext. +201555035523

shimaa.3m.sh@gmail.com

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
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 groups in NCT07139392
Study groupRoleWhat they receive
connective tissue graftPlacebo comparatorSemi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction
Receives: Biological: connective tissue graft
albumin-PRFActive comparatorAlbumin- 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.

  1. 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.

  1. First posted24 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion20 Sep 2025 (estimated)
  4. Study completion23 Sep 2025 (estimated)

Resources

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)
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

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.

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