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NCT06371027 Clinical Trial

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

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06371027
Other study ID # RECO6U/22-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date April 1, 2024

Study information
Verified date April 2024
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 1, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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
• 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
• Minimally Invasive Surgery Technique (MIST)
Minimally Invasive Surgery Technique in the area that contains an intraosseous defects with Probing depth (PD) =5 mm

Locations
Country Name City State
Egypt faculty of dentistry O6U Giza

Sponsors (1)
Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects The primary outcome variable in this clinical study will be the change in bone fill as measured by cone beam CT 6 months after surgery
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Active, not recruiting NCT03433066 - Advanced Platelet Rich Fibrin in Periodontal Angular Defects N/A