This randomized clinical trial evaluates the clinical and microbiological (microbial complexes and changes in the diversity of the submucosal biofilm) effects of MTZ+AMX as adjuncts to anti-infectious surgical treatment plus Er: YAG in the treatment of peri-implantitis.
Peri-implantitis is a pathological condition characterized by inflammation of peri-implant connective tissues and progressive peri-implant bone. Recently, the therapeutic protocol using non-surgical debridement associated with the combination of systemic metronidazole (MTZ) and amoxicillin (AMX) has not been shown to be effective in controlling the disease. These unfavorable results may have occurred due to the limitation in the change of the submucosal microbiological profile due to mechanical difficulties in the decontamination of the implant threads. Therefore, this randomized clinical trial (RCT) aimed to evaluate the clinical and microbiological (microbial complexes and changes in the diversity of the submucosal biofilm) effects of MTZ+AMX as adjuncts to anti-infectious surgical treatment plus Er:YAG in the treatment of peri-implantitis. Ninety-four subjects with untreated peri-implantitis are being included and will be randomly assigned to receive (i) open flap debridement plus Er:YAG irradiation alone (control), or (ii) with adjunctive systemically administered MTZ (400 mg) + AMX (500 mg) thrice a day (TID) for 14 days (test). Subjects will be monitored up to 12 months post-treatment. Submucosal biofilm samples from the deepest site of each implant with peri-implantitis will be collected in duplicate per patient: at baseline and at 3, 6 and 12 months post-therapy and analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species, and at baseline, 3 and 12 months post-treatment for 16S rRNA sequencing (Ion Torrent PGM System). The primary outcome variable of this trial will be the difference between treatment groups for the change in CAL from baseline to 12 months. The significance of differences in each group (over the course of the study) will be sought using the Student's-t test; and among groups (at each time point) using either ANOVA /ANCOVA or Kruskal Wallis tests and post-hoc analyses, depending on normality of the data. Fisher's exact test will be used to compare differences in the frequency of gender. Statistical significance will be set at 5%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
After local anesthesia (2% lidocaine with1:100,000 epinephrine), intrasulcular incisions will be performed to create a horizontal flap extending beyond the adjacent teeth and/or implants. Buccal and lingual full-thickness flaps will be dissected, and granulation tissue will be removed to expose the implant threads and bone defect. The flap will be repositioned in its original position and stabilized with interrupted sutures, which will be removed after 10 days.
An Er:YAG laser (Lite Touch, Light Instruments, Israel) will be used, with an irradiation energy of 20 mJ, frequency of 20 Hz, output power of 0.4 W, and an energy density of 2.76 J/cm2. An 8 mm long sapphire tip will be used in the respective handpiece and not in contact with the titanium surface, with concomitant water spray irrigation, under air 6 and water spray 6, the irradiation angle will be 90 degrees, at a focal distance of 2 mm, with spot size diameter of 1.3 mm
University of Guarulhos
Guarulhos, São Paulo, Brazil
Difference between treatment groups for the change in the clinical attachment level (CAL).
Time frame: 12 months.
Percentage of patients (and implants) reaching the following clinical endpoint for treatment: PD< 5mm, absence of BOP and no further bone loss.
Time frame: 12 months.
Mean plaque index.
Time frame: Baseline, 3, 6 and 12 months.
Mean gingival index.
Time frame: Baseline, 3, 6 and 12 months.
Percentage of sites with bleeding on probing.
Time frame: Baseline, 3, 6 and 12 months.
Percentage of sites with suppuration.
Time frame: Baseline, 3, 6 and 12 months.
Probing depth.
Time frame: Baseline, 3, 6 and 12 months.
Occurrence of headache obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).
Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (beginning after open flap debridement).
Time frame: 14 days after taking antibiotic.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Proportions of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months.
Counts of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months.