Clinical trial NCT05772299: Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device
Official title: Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: Clinical study
Bleeding on probing
Pus
Er:Yag laser
Ultrasonic device
Lead sponsor: Kristianstad University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 45
Sex: ALL
Minimum age (years): 23
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 1 peri-implant site with probing depth ≥ 4 mm combined with bleeding and or pus on probing
* bone loss ≤ 2 mm measured from the implant shoulder (as a consequence of remodelling during the healing process)

Exclusion Criteria:

* Subjects with uncontrolled diabetes HbA1c \>6.5
* Subjects requiring prophylactic antibiotics
* Subjects taking prednisolone
* Subjects taking medications known to have effects on gingival overgrowth

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: Baseline
measure: Bleeding on probing (BOP)
timeFrame: 1 month
measure: Bleeding on probing (BOP)
timeFrame: 3 months
measure: Bleeding on probing (BOP)
timeFrame: 6 months
measure: Probing pocket depth (PPD)
timeFrame: Baseline
measure: Probing pocket depth (PPD)
timeFrame: 1 month
measure: Probing pocket depth (PPD)
timeFrame: 3 months
measure: Probing pocket depth (PPD)
timeFrame: 6 months
measure: Pus
timeFrame: Baseline
measure: Pus
timeFrame: 1 month
measure: Pus
timeFrame: 3 months
measure: Pus
timeFrame: 6 months
Secondary outcomes:
measure: Recession of the peri-implant mucosal margin
timeFrame: Baseline
measure: Recession of the peri-implant mucosal margin
timeFrame: 6 months
measure: Bone level (peri-apical radiographs)
timeFrame: Baseline
measure: Bone level (peri-apical radiographs)
timeFrame: 6 months
measure: Implant loss
timeFrame: Baseline
measure: Implant loss
timeFrame: 1 month
measure: Implant loss
timeFrame: 3 months
measure: Implant loss
timeFrame: 6 months
measure: Treatment time
timeFrame: Baseline
measure: Treatment time
timeFrame: 3 months
measure: Treatment time
timeFrame: 6 months
measure: Quality of life (QoL)
timeFrame: Baseline
measure: Quality of life (QoL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: University of Kristianstad
Study officials:
affiliation: Kristianstad University
name: Stefan Renvert, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aoki A, Sasaki KM, Watanabe H, Ishikawa I. Lasers in nonsurgical periodontal therapy. Periodontol 2000. 2004;36:59-97. doi: 10.1111/j.1600-0757.2004.03679.x. No abstract available.
citation: Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
citation: Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
citation: Lin GH, Suarez Lopez Del Amo F, Wang HL. Laser therapy for treatment of peri-implant mucositis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):766-782. doi: 10.1902/jop.2017.160483.
citation: Renvert S, Lessem J, Dahlen G, Lindahl C, Svensson M. Topical minocycline microspheres versus topical chlorhexidine gel as an adjunct to mechanical debridement of incipient peri-implant infections: a randomized clinical trial. J Clin Periodontol. 2006 May;33(5):362-9. doi: 10.1111/j.1600-051X.2006.00919.x.
citation: Renvert S, Persson GR, Pirih FQ, Camargo PM. Peri-implant health, peri-implant mucositis, and peri-implantitis: Case definitions and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S304-S312. doi: 10.1002/JPER.17-0588.
citation: Takasaki AA, Aoki A, Mizutani K, Kikuchi S, Oda S, Ishikawa I. Er:YAG laser therapy for peri-implant infection: a histological study. Lasers Med Sci. 2007 Sep;22(3):143-57. doi: 10.1007/s10103-006-0430-x. Epub 2007 Jan 12.