Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial

October 6 University

Status: Completed

Conditions: Intrabony Periodontal Defect

Treatments: Procedure: Minimally Invasive Surgery Technique (MIST); Procedure: Minimally Invasive Surgery Technique (MIST) + collagen membrane; Procedure: Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT06371027

RECO6U/22-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

Minimally Invasive Surgery Technique (MIST)

Active Comparator group

Description:

Minimally Invasive Surgery Technique in the area that contains an intraosseous defects with Probing depth (PD) ≥5 mm

Treatment:

Procedure: Minimally Invasive Surgery Technique (MIST)

Minimally Invasive Surgery Technique (MIST) + Collagen Membrane

Experimental group

Description:

Minimally Invasive Surgery Technique + Collagen Membrane placement in the area that contains an intraosseous defects with Probing depth (PD) ≥5 mm

Treatment:

Procedure: Minimally Invasive Surgery Technique (MIST) + collagen membrane

Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane

Experimental group

Description:

Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane placement in the area that contains an intraosseous defects with Probing depth (PD) ≥5 mm

Treatment:

Procedure: Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane