Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The goal of the clinical trial is to compare laser therapy with ultrasonic therapy in
      patients with inflammation in the tissue surrounding single implants (peri-implant
      mucositis). The outcomes are bleeding on probing (BOP), pocket depth, suppuration, recession
      of the peri-implant mucosal margin, the treatment time and changes in bone levels before and
      after treatment in the test, and control group respectively. The quality of life will be
      measured from a standardized protocol.

      The hypothesis is that treatment with laser therapy in patients with peri-implant mucositis
      will show less inflammation with less bleeding and a better pocket closure compared to the
      treatment with the ultrasound.
    

Detailed description: 
      Data from the clinical treatment will be registered in medical records. In parallel, clinical
      data will be documented in a study protocol and saved in a safe together with a code list in
      accordance with a standard operation procedure at the clinic.The protocol with the specific
      treatment procedure (test or control) will not be opened until the study is completed and
      only by authorized persons with access to the data in the study such as, the principal
      investigator and the statisticians.

      Variables used in the study originates from an international world workshop on the
      classification of periodontal and peri-implant diseases and conditions in 2018. In accordance
      with the working group a diagnosis of peri-implant mucositis should include bleeding on
      probing and or pus and no bone loss (X-ray). In this study the primary outcomes are bleeding
      on probing (BOP) and or pus and pocket depth,

      The aim is to assess the clinical outcome over 6 months following treatment with non-surgical
      debridement using an Er:Yag laser device (AdvErL EVO, Morita corporation, Japan) (Test group)
      or with the use of mechanical therapy using an ultrasonic device with a specially designed
      tip (EMS, Switzerland) (Control group). An active comparator (Control group) was compared to
      an experimental arm (Test group).

      Patients will therefore be randomized into a test or control group. Inclusion criteria will
      follow a full mouth routine periodontal examination, including analysis of available
      radiographs.

      All measurements will be performed by a dental hygienist who is blinded for the specific
      treatment test or control. A periodontist will perform all the treatments and is therefore
      not blinded. Upon the final appointment the specific arm of treatment will be registered by
      the periodontist in the patient journal.

      All patients will be given oral and written information about the study and sign a written
      informed consent. The patients will be informed that they could drop off whenever they want
      without any explanations. The ethical board approved the study.

      The test group will be treated using the Er:Yag laser device.The control group will be
      treated using an ultrasonic device with peek coated tips (EMS, Switzerland). Following
      treatment all patients, independent of group, will be instructed in proper home care using a
      toothbrush and interproximal aids as needed.

      Study design:

        -  Baseline: Clinical registrations and treatment

        -  1 month: Clinical registrations

        -  3 months: Clinical registrations and treatment

        -  6 months: Clinical registrations and treatment

      In addition, the instrument Oral Health Impact Profile (OHIP) will be used as a measurement
      of quality of life.

      Adverse events will be evaluated at each visit. If a patient should require any treatment
      during the study the necessary treatment will be provided and according to the standard of
      care. If adverse events related to the treatment they will be recorded. The investigation
      will be performed according to the principles of the Declaration of Helsinki on
      experimentation involving human subjects.

      Participant not fulfilling the study will be reported in the patient journal as not completed
      and statistically noted as missing data.

      From the statistical power analysis 38 individuals were minimum to reach a clinically
      significant difference. The power analysis was based on: if bleeding on probing (BOP) is
      reduced with 30% ± 10 in the test group and with a 30% decrease in the control group is to be
      detected at alpha =0.05 and a power of beta= 0.2. Hence it is foreseen to incorporate 45
      subjects in the study if some of the individuals will not fulfil the study.

      The IBM SPSS version 28.0 statistical software package (SPSS Inc., Armonk, NY, USA) for
      personal computer will be used in the statistical analyses.

      Statistics will be calculated as means with standard deviation (SD). Independent t-tests
      (equal variance not assumed) paired t-test and one-way ANOVA test will be used to compare
      inter and intra-group differences. Non-parametric chi-square test will be used for
      categorical variables. Statistical significance will be set with 80 percent at p < 0.05. Non
      visits will be recorded as missing data in the statistics.
    

Intervention name(s): Er:Yag laser; EMS ultrasound
Intervention type(s): Radiation; Device
Intervention description(s): Submucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water.; Submucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Test group: will be treated using the Er:Yag laser device (AdvErL EVO, Morita Corporation, Japan). The tip is placed in the pocket mesially, lingually, distally and buccally.
Control group: will be treated using an ultrasonic device with PEEK coated tips (EMS, Switzerland). The tip is placed in the pocket mesially, lingually, distally and buccally.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical study; Bleeding on probing; Pus; Er:Yag laser; Ultrasonic device