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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07139392
Acronym
ALB-PRF & CTG
Enrollment
30
Registered
2025-08-24
Start date
2025-09-01
Completion date
2025-09-23
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papilla Reconstruction

Keywords

ALB-PRF, papilla, connective tissue, reconstruction, MINST

Brief 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 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

* 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

BIOLOGICALconnective tissue graft

Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate

Sponsors

shaimaa hamdy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Papilla Height Gain6 months follow upPapilla Height Gain (measured from contact point to papilla tip)

Contacts

Primary Contactshaimaa Hamdy, lecturer of Periodontology
shimaa.3m.sh@gmail.com+201030576405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026