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

NCT ID: NCT06371027

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-04-01

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.

Conditions

Intrabony Periodontal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minimally Invasive Surgery Technique (MIST)

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

Group Type: ACTIVE_COMPARATOR

Minimally Invasive Surgery Technique (MIST)

Intervention Type: PROCEDURE

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

Minimally Invasive Surgery Technique (MIST) + Collagen Membrane

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

Group Type: EXPERIMENTAL

Minimally Invasive Surgery Technique (MIST) + collagen membrane

Intervention Type: PROCEDURE

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

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

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

Intervention Type: PROCEDURE

Minimally Invasive Surgery Technique (MIST) + collagen membrane

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

Intervention Type: PROCEDURE

Minimally Invasive Surgery Technique (MIST)

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hamdy Hamed El-Shesheny

principle investigator. mohamed hamdy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of dentistry O6U

Giza, , Egypt

Countries

Egypt

Other Identifiers

RECO6U/22-2022

Identifier Type: -

Identifier Source: org_study_id