Clinical trial NCT03753958: Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-Implantitis Lesions
Official title: Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-implantitis Lesions: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peri-Implantitis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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%.

Primary outcomes:
measure: Change in plaque index
timeFrame: Baseline, 30 days and 60 days after treatment.
measure: Change in probing bleeding
timeFrame: Baseline, 30 days and 60 days after treatment.
measure: Change in probing depth
timeFrame: Baseline, 30 days and 60 days after treatment.
measure: Change in gingival recession
timeFrame: Baseline, 30 days and 60 days after treatment.
measure: Change in loss of clinical insertion
timeFrame: Baseline, 30 days and 60 days after treatment.
Secondary outcomes:
measure: Microbiological examination (change in CFUs (Colony Forming Units))
timeFrame: Baseline and immediately after treatment.
Other outcomes:
Locations:
Study officials:
References: