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| ID | Type | Description | Link |
|---|---|---|---|
| committee 1165 | Other Identifier | ethical committee faculty of dentistry minia university |
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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
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:
Materials and methods:
Study Design:
Type: Randomized Controlled Clinical Trial
Duration: 6 months follow-up
Groups:
Sample Selection:
Inclusion Criteria:
Exclusion Criteria:
Preoperative Phase:
Surgical Technique:
Postoperative Protocol:
Outcome Measures:
Primary Outcome:
o Papilla Height Gain (measured from contact point to papilla tip)
Secondary Outcomes:
Statistical Analysis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| connective tissue graft | Placebo Comparator | Semi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction |
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| albumin-PRF | Active Comparator | Albumin- PRF for papilla reconstruction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin (5% serum-protein solution containing immunoglobulins) | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Papilla Height Gain | Papilla Height Gain (measured from contact point to papilla tip) | 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shaimaa Hamdy, lecturer of Periodontology | Contact | +201030576405 | +201555035523 | shimaa.3m.sh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| shaimaa Hamdy, lecturer | lecturer of periodontology Nahda University | Principal Investigator |
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| Label | URL |
|---|---|
| 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 side | View source |
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After completing the study, I will share all the data of the study
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Sample Selection:
Inclusion Criteria:
Exclusion Criteria:
Preoperative Phase:
Surgical Technique:
Postoperative Protocol:
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| connective tissue graft | Biological | Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate |
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