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Not yet recruiting NCT07139392

A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla

Phase III Interventional Papilla Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Albumin (5% serum-protein solution containing immunoglobulins), connective tissue graft.
Who it may be relevant to
Registry conditions: Papilla Reconstruction. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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:

o 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

Interventions

  • Biological Albumin (5% serum-protein solution containing immunoglobulins)
    * 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 * Postop
  • Biological connective tissue graft
    Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate

Primary outcome measures

  • Papilla Height Gain [Time frame: 6 months follow up]

Eligibility criteria

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 the target site
  • History of systemic diseases or medications affecting healing
  • Pregnant or lactating women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07139392 · ALB -PRF in papilla · committee 1165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗