Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05031923
Other study ID # waiting..
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2021
Est. completion date August 2024

Study information

Verified date April 2024
Source Kafrelsheikh University
Contact Dalia R Issa, PhD
Phone 01007753636
Email dalia_rasheed@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Patients were all healthy and free from any systemic disease; - no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study; - patients were willing and able to return for multiple follow-up visits; - good levels of oral hygiene Exclusion Criteria: - Pregnant and lactating female patients, - smokers, - alcoholics, - those receiving any medication that could affect healing of soft or hard tissue

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
SMV and antimicrobial photodynamic therapy
Application of SMV and antimicrobial photodynamic therapy in intrabony defects
SMV application
Application of SMV without antimicrobial photodynamic therapy in intrabony defects

Locations

Country Name City State
Egypt Faculty of Dentistry, Kafrelsheikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical evaluation and measurements of the defect in millimeters Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters 9 months
Primary Radiographic evaluation and measurements of the defect in millimeters Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters 9 months
See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Completed NCT04478864 - Knowledge, Practice and State of Periodontal Health
Completed NCT03507868 - YKL-40 and IL-6 Levels in Periodontal Disease
Completed NCT05720481 - Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels N/A
Recruiting NCT06052150 - Oral Health In Cirrhosis of the Liver (ORACLE)
Recruiting NCT06025955 - Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement. N/A
Recruiting NCT03510702 - SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Completed NCT05631600 - Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study Phase 2/Phase 3
Active, not recruiting NCT05068778 - Development of an AI App to Improve Compliance in Periodontal Maintenance Patients
Not yet recruiting NCT05178563 - Mechanisms of Acute Inflammation Following Periodontal Treatment N/A
Recruiting NCT06224699 - Toothpaste With Sodium Carbonate in Patients With Gingivitis N/A
Recruiting NCT06086821 - Clinical Relevance of Different Time of Periodontal Re-evaluation N/A
Not yet recruiting NCT05721313 - Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study N/A
Completed NCT06040944 - Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients
Completed NCT06306937 - Serum Levels of Vitamin D and IL8 in Patients With Periodontitis
Recruiting NCT04669717 - Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies Phase 4
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Not yet recruiting NCT03588507 - Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects N/A
Completed NCT04017078 - Assessment of Carotid Artery Calcifications