The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year.
Peri-implantitis is a major complication for dental implant patients, with its prevalence estimated in the order of 10% of implants and 20% of patients after 5 to 10 years of implant placement. When left untreated, peri-implantitis may cause progressive tissue destruction, esthetic complications and, eventually, implant loss. Despite numerous clinical trials and systematic reviews, studies have failed to identify a standardized protocol for the treatment of such conditions. Still, current literature and expert opinions recommend mechanical debridement of the implant followed by early evaluation and surgical intervention, implant decontamination using a wide variety of mechanical and chemical methods, then adjunctive systematic antibiotics. However, given the aggressive nature of surgical interventions, the inherent difficulty of decontaminating the implants' rough surfaces with conventional methods, in addition to the growing concerns over antibiotic resistance, the search for alternative approaches has become imperative. Since implant decontamination is the key aspect to resolution of peri-implantitis, different mechanical and chemical methods have been tested in that respect. In recent years, lasers have been attracting significant attention in this particular field. Diode lasers, in particular, have been shown to have potent bactericidal and photobiomodulatory effects promoting wound healing and tissue regeneration. Therefore, the aim of this randomized controlled clinical trial is to evaluate the clinical and patient-centered outcomes of non-surgical debridement with adjunctive repeated diode laser application in comparison with conventional surgical treatment with adjunctive systemic antibiotics for treatment of peri-implantitis lesions following an observation period of one year. The primary objective is to evaluate the clinical and patient-centered outcomes of non-surgical mechanical debridement with adjunctive repeated diode laser application (test) in comparison with conventional surgical treatment and adjunctive systemic antibiotics (control), for treatment of peri-implantitis lesions, following an observation period of one year. 40 subjects will be randomly distributed into two parallel groups: 1. Test group (n= 20); receiving non-surgical mechanical debridement and adjunctive diode laser application at days 0, 7 and 14. 2. Control group (n= 20); receiving initial mechanical debridement at day 0, followed by open flap debridement and prescription of post-operative systemic antimicrobials at day 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Laser treatment of the peri-implantitis lesion includes mechanical debridement of the implant using an ultrasonic device and plastic curettes followed by diode laser sub-mucosal application for 90 seconds. This is repeated two more times at one-week intervals.
Mechanical debridement of the implant will be done in a similar manner to the test group (without laser application) followed by open flap debridement 2 weeks after, and post-operative prescription of Amoxicillin and Metronidazole systemic antibiotics 3 times per day for a period of 1 week
University of Geneva
Geneva, Genève 4, Switzerland
Resolution of the peri-implantitis
Defined as A absence of probing depths \> 4 mm, bleeding on probing or suppuration at the end of the observation period
Time frame: 12 months
Types and frequencies of adverse events
Any adverse events related or unrelated to the treatment administered is recorded at the time and appropriate treatment is performed. The frequency, duration and intensity is also recorded.
Time frame: 12 months
Patient reported outcomes at 1 week
A visual analogue scale is used to evaluate post-operative discomfort and patient's perception of the administered treatment 1 week post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating absence of pain and 100 being the worst pain imaginable.
Time frame: 1 week post-operatively
Patient reported outcomes at 12 months
A visual analogue scale is used to evaluate general patient's perception of the administered treatment 12 months post-operatively.The scale measures a total of 100 mm ranging between 0-100; 0 indicating lack of discomfort or pain and complete satisfaction and 100 being completely unsatisfied and/or with persisting pain or other symptoms.
Time frame: 12 months
Change in marginal bone levels
Changes in peri-implant marginal bone levels are measured on intra-oral radiographs taken at baseline and 12 months post-operatively. Two independent examiners perform measurements and mean values are taken. This outcome is only calculated 12 months postoperatively.
Time frame: 12 months
Differences between groups regarding changes in mean marginal bone level changes
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Comparison in mean marginal bone level changes (outcome 4) are performed between the test and control groups
Time frame: 12 months
Number of residual pockets > 4 mm
Number of residual peri-implant pockets exceeding 4 mm are measured around all included implants at the end of the observation period to asses the presence of any residual peri-implant soft-tissue inflammation
Time frame: 12 months
Changes in probing depth
The change in mean probing depth between baseline and 12 months is calculated to assess treatment outcomes and disease resolution around all included implants. This outcome is calculated only once 12 months post-operatively.
Time frame: 12 months