Clinical trial NCT06371027: Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
Official title: Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: intrabony defects
regenerative membranes
minimally invasive techniques
CBCT
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects.

Detailed description: Periodontitis is a bacterially induced chronic inflammation of the periodontium that extends beyond the gingiva and involves progressive and irreversible destruction of the connective tissue attachment of the teeth.The treatment involves debridement of the tooth surface and the adjacent areas employing scaling, root planing and periodontal flap surgery. While scaling and root planing are non-surgical treatment modalities and are conservative; periodontal flap surgery gains access to the underlying bone for complete debridement achieving pocket depth reduction, periodontal regeneration, and maintenance of periodontium in healthy condition feasible by routine home care methods by the patient.

Guided tissue regeneration (GTR) therapy is playing a key role in the management of intrabony defects. Current resorbable and non-resorbable membranes act as a physical barrier to avoid connective and epithelial tissue down-growth into the defect, favoring the regeneration of periodontal tissues. However, these conventional membranes possess many structural, mechanical, and bio-functional limitations and the "ideal" membrane for use in periodontal regenerative therapy has yet to be developed. Based on a graded-biomaterials approach, we have hypothesized that a biologically active and spatially designed and functionally graded nanofibrous material that mimics closely the native extracellular matrix ECM could succeed as the next generation of GTR membranes for periodontal tissue engineering. In the current study, using a minimally invasive surgical approach, we will compare a novel silk fibroin (SF) nanofiber membrane to collagen membrane as a regenerative treatment of intrabony periodontal defects.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years old. 2. Patients with periodontitis Stage III Grade C. 3. Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible. 4. Probing depth (PD) ≥5 mm at the site of intraosseous defects 4 weeks following initial therapy. 5. Periodontal 2- or 3-wall intrabony defects (IBDs), measuring ≥3 mm from the alveolar crest to the defect base, estimated by radiographic evaluation (Periapical X-ray). 6. Absence of a history of periodontal surgery at the involved sites in the last 6 months. 7. History of compliance with oral hygiene instructions and periodontal recall. 8. Full mouth plaque score and bleeding on probing score ≤20% after phase I therapy.

Exclusion Criteria:

* 1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.24 2. Pregnant and lactating women 3. Current use of any form of tobacco.

Primary outcomes:
measure: Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of dentistry O6U
Study officials:
References: