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IRCT20210212050339N1 IRCT 2021-08-18 Islamic Azad University The Effect of Scaling with Photodynamic Therapy on IL-6 and IL-1B levels in patients with Peri-implantitis The effect of Scaling with Photodynamic Therapy or Subgingival Irrigation with Chlorhexidine on IL-6 and IL-1B levels in patients with Peri-implantitis 2021-07-06 anticipated 66 Complete https://irct.ir/trial/54270 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method will be used; at first, patients will be stratified according to their ages (above 50 and under 50), followed by random selection of a block size of 4 or 6, and afterwards, patients will be divided into treatment and control groups accordingly, Blinding description: The dentist performing the assessment will be blind to the patient group. N/A Peri-implantitis. Intervention 1: Intervention group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Photodynamic Therapy (320nm diode laser, 50mW, 90s continuously along with Methylene Blue 1% Photosensitiser; Photodynamic Therapy will be repeated 2 weeks later) + Chlorhexidine mouthwash. Intervention 2: Control group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Chlorhexidine (0.2%) irrigation with a blunt needle + Chlorhexidine mouthwash. Yes - There is a plan to make this available What will be shared: Collected data after de identification is available to share. When: 6 months after publication To whom: People working in academic institutions. Conditions: Statistical analysis of data is allowed after applicator presents required credentials for working in academic institutions Where to obtain: Via contacting : n_esfahanizadeh@yahoo.com How to obtain: Sending credentials to mentioned e-mail Comments:
public Nasrin Esfahanizadeh
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
Tehran Iran (Islamic Republic of) 19585175 +98 21 2256 4571 n_esfahanizadeh@yahoo.com Islamic Azad University scientific Nasrin Esfahanizadeh
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
Tehran Iran (Islamic Republic of) 19585175 +98 21 2256 4571 n_esfahanizadeh@yahoo.com Islamic Azad University Iran (Islamic Republic of) At least one implant with peri-implantitis The implant has been in function for at least one year Screw-type implants with rough surface Partial edentulous patients with healthy or treated periodontal condition who are in maintenance care program. Total plaque score ≤ 25 18-80 years of age 18 years 80 years Both Use of Antibacterial or Non-steroidal Anti-inflammatory drugs within 3 months prior to diagnosis Implant mobility Pregnancy or breastfeeding History of autoimmune diseases, malignancy, cardiovascular insufficiency, or acute diseases of other organs History of Peri-implantitis or Periodontal treatment in last 6 months Uncontrolled Diabetes (HbA1c > 7%) Tobacco use Use of Systemic Antibiotic Therapy for Prophylaxis of Endocarditis Infectious diseases such as HIV, TB and Hepatitis Failure to sign a written consent Those treated with any drugs which may affect soft tissue conditions; such as Phenytoin, Cyclosporine, etc. for 2 weeks or more in a month, before the initial evaluation. Head and neck radiotherapy Alcohol or drug abuse M27.62 Post-osseointegration biological failure of dental implant Treatment - Other Treatment - Other Intervention group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Photodynamic Therapy (320nm diode laser, 50mW, 90s continuously along with Methylene Blue 1% Photosensitiser; Photodynamic Therapy will be repeated 2 weeks later) + Chlorhexidine mouthwash Control group: Scaling, Root Planing, and Mechanical Debridement of dental implants with Ti curettes + Chlorhexidine (0.2%) irrigation with a blunt needle + Chlorhexidine mouthwash Interleukin 1-b Levels in Gingival Crevicular Fluid. Timepoint: At baseline, 3 months, and 6 months after treatment. Method of measurement: The Enzyme-linked Immunosorbent Assay test. Interleukin 1-b Levels in Gingival Crevicular Fluid. Timepoint: At baseline, 3 months, and 6 months after treatment. Method of measurement: The Enzyme-linked Immunosorbent Assay test. Islamic Azad University Approved 2021-06-01 Ethics committee of Azad Tehran University of Medical Sciences Unit B5-1, Sa'adi Tower, Hormozan Street, Shahrak-e-Gharb Tehran Tehran Iran (Islamic Republic of)