Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-implantitis Lesions: A Randomized Controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Peri-Implantitis
- Sponsor
- University of Nove de Julho
- Enrollment
- 20
- Primary Endpoint
- Change in loss of clinical insertion
- Last Updated
- 7 years ago
Overview
Brief Summary
The elimination of pathogenic microorganisms from the muco-gingival tissue and implant pockets system is one of the main aspects for success in the treatment of peri-implantitis. The purpose of this study is to conduct a blinded and randomized clinical trial to evaluate the effectiveness of photodynamic therapy in the treatment of peri-implantitis. Twenty implants with peri-implantitis will be selected. Implants will be randomly divided into two groups (n = 10), Group 1: control - conventional treatment and Group 2: conventional treatment and antimicrobial photodynamic therapy (aPDT). aPDT will be performed after the purse removal service in sites with pockets greater than or equal to 5 mm. The photosensitizer will be PapaMblue®, which will be deposited in the peri-implant pockets, with pre-irradiation time of 1 min. Next, the laser emitting a wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 in the buccal and mesial regions will be applied. The distribution of the data within each group will be evaluated and the variances will be checked to choose a more appropriate statistical analysis. The sample calculation is based on the literature and the significance level of 5% will be adopted.
Investigators
Renato Araujo Prates
Principal Investigator
University of Nove de Julho
Eligibility Criteria
Inclusion Criteria
- •Have peri-implantitis;
- •Have at least one implant with a clinical depth of probing equal to or greater than 5 mm;
- •Age range of 18 to 65 years.
Exclusion Criteria
- •Smokers or ex-smokers who stopped the habit less than 12 months before the screening;
- •Have decompensated diabetes;
- •Pregnant;
- •Use antibiotics in the last 3 months12;
- •Make use of anti-inflammatories or have coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia, immunosuppression);
- •In orthodontic treatment;
- •Patients who maintained a biofilm index higher than 25%.
Outcomes
Primary Outcomes
Change in loss of clinical insertion
Time Frame: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of loss of clinical insertion. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in probing bleeding
Time Frame: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing bleeding. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in probing depth
Time Frame: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of probing depth. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in gingival recession
Time Frame: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of gingival recession. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Change in plaque index
Time Frame: Baseline, 30 days and 60 days after treatment.
For the evaluation of clinical parameters, a single trained, calibrated examiner will examine 6 sites of each implant with a 15mm North Carolina millimeter probe (Hu-Friedy, Chicago, IL, USA) for the measurement of plaque index. The evaluation will be performed at the beginning of treatment, 30 and 60 days after the first application of aPDT.
Secondary Outcomes
- Microbiological examination (change in CFUs (Colony Forming Units))(Baseline and immediately after treatment.)