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

NCT06371027 | Completed

• 1 other identifier: RECO6U/22-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Keywords

intrabony defects; regenerative membranes; minimally invasive techniques; CBCT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Minimally Invasive Surgery Technique (MIST)

ACTIVE COMPARATOR

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

Procedure: Minimally Invasive Surgery Technique (MIST)

Minimally Invasive Surgery Technique (MIST) + Collagen Membrane

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

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

Minimally Invasive Surgery Technique (MIST) + collagen membrane 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) + Collagen Membrane

Minimally Invasive Surgery Technique (MIST) PROCEDURE

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

Minimally Invasive Surgery Technique (MIST)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

faculty of dentistry O6U

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator. mohamed hamdy

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: November 1, 2022
• Primary Completion: February 15, 2024
• Study Completion: April 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

EG (1)