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
Verified date | April 2024 |
Source | October 6 University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of dentistry O6U | Giza |
Lead Sponsor | Collaborator |
---|---|
October 6 University |
Egypt,
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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