Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-Implantitis Lesions
- Conditions
- Peri-Implantitis
- Registration Number
- NCT03753958
- Lead Sponsor
- University of Nove de Julho
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- Smokers or ex-smokers who stopped the habit less than 12 months before the screening;
- Have decompensated diabetes;
- Anemia;
- Cancer;
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in loss of clinical insertion 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 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 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 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 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 Outcome Measures
Name Time Method Microbiological examination (change in CFUs (Colony Forming Units)) Baseline and immediately after treatment. The microbiological examination will be performed from subgingival biofilm samples collected from the mesial region of the peri-implant pockets of the selected implants. Two collections will be performed at each experimental site before and immediately after the aPDT and irradiation procedures. For the collection of the subgingival biofilm, a relative isolation of the teeth with cotton rollers will be performed, the supra-gingival biofilm will be removed with sterile gauze, and the subgingival biofilm sample will be obtained by inserting a sterile absorbent paper tip (no. 30) into the inside of the peri-implant pocket, being held in place for 30 s. The tips will be removed and stored in properly identified sterile plastic microtubes, with each paper cone being stored in a different microtube.
The samples will be used to determine the CFUs (Colony Forming Units).