Clinical trial NCT04565886: Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application
Official title: Clinical and Radiographic Outcomes Following Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application: A 12-month Double-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised placebo controlled monocentric trial
Primary purpose: TREATMENT

Brief summary: Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.

Detailed description: Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. To increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:

* Change at deepest PPD (mm)
* Change in probing attachment level (PAL) (mm)
* Change in the % of implants with BoP / SUP
* Mean radiographic bone fill (mm) at mesial and distal sites
* Change in width of keratinized mucosa (KM) (mm)
* Change in microbial samples composition at 6 and 12 months
* Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
* Change in peri-implant crevicular fluid (PICF) composition

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients enrolled in regular supportive periodontal therapy (SPT)
* Tissue level (TL) implants with an SLA surface supporting single-unit crowns (SUCs) or fixed dental prostheses (FDPs)
* Pocket Probing Depth (PPD) \> 5 mm
* Presence of BoP and /or SU
* Radiographic evidence of crestal bone loss ≤ 2mm based on periapical radiographs after delivery of the final restoration
* Cleansable cemented or screw-retained restoration
* Presence of at least 2 mm of keratinized and attached mucosa (KM)
* Signed informed consent

Exclusion Criteria:

* Systemic diseases that could interfere with the treatment outcome (e.g. uncontrolled diabetes mellitus, chemotherapy, etc.)
* Previous peri-implantitis treatment
* Full-Mouth Plaque Score (FMPS) \> 25%
* Full-Mouth Bleeding Score (FMBS) \> 25%
* Cigarette smoking \> 10 cig./day
* Removable implant-supported restorations
* Implant mobility

Primary outcomes:
measure: Change in peri-implant pocket probing depth (PPD)
timeFrame: at 12 months
Secondary outcomes:
measure: Change at deepest PPD (mm)
timeFrame: at 12 months
measure: Change in probing attachment level (PAL) (mm)
timeFrame: at 12 months
measure: Change in the % of implants with BoP / SUP
timeFrame: at 12 months
measure: Mean radiographic bone fill (mm) at mesial and distal sites
timeFrame: at 12 months
measure: Change in width of keratinized mucosa (KM) (mm)
timeFrame: at 12 months
measure: Change in microbial samples composition
timeFrame: at 6 and 12 months
measure: Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
timeFrame: at 12 months
measure: Change in peri-implant crevicular fluid (PICF) composition
timeFrame: at 12 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Periodontology, University of Bern
Study officials:
References: