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Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Er:Yag laser
EMS ultrasound
Sponsored by
Kristianstad University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring Clinical study, Bleeding on probing, Pus, Er:Yag laser, Ultrasonic device

Eligibility Criteria

23 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kristianstad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Er:Yag laser treatment

Ultrasonic device treatment

Arm Description

The experimental (test) group will receive the following treatment: The submucosal debridement will be performed with an Er:Yag laser (AdvErL EVO, Morita Corporation, Japan). The P-400 tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.

The active comparator (control) group will receive the following treatment: The submucosal debridement will be performed by a piezoelectric ultrasonic device with a PEEK coated tip (EMS, Switzerland). The tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.

Outcomes

Primary Outcome Measures

Bleeding on probing (BOP)
millimeter
Bleeding on probing (BOP)
millimeter
Bleeding on probing (BOP)
millimeter
Bleeding on probing (BOP)
millimeter
Probing pocket depth (PPD)
millimeter
Probing pocket depth (PPD)
millimeter
Probing pocket depth (PPD)
millimeter
Probing pocket depth (PPD)
millimeter
Pus
Presence or abscence
Pus
Presence or abscence
Pus
Presence or abscence
Pus
Presence or abscence

Secondary Outcome Measures

Recession of the peri-implant mucosal margin
millimeter
Recession of the peri-implant mucosal margin
millimeter
Bone level (peri-apical radiographs)
millimeter on Xray
Bone level (peri-apical radiographs)
millimeter on Xray
Implant loss
Prevalence
Implant loss
Prevalence
Implant loss
Prevalence
Implant loss
Prevalence
Treatment time
minutes
Treatment time
minutes
Treatment time
minutes
Quality of life (QoL)
Questionnaire "Oral Health Impact Proflie" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)
Quality of life (QoL)
Questionnaire "Oral Health Impact Profile" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)

Full Information

First Posted
March 6, 2023
Last Updated
October 9, 2023
Sponsor
Kristianstad University
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1. Study Identification

Unique Protocol Identification Number
NCT05772299
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
August 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kristianstad University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
Clinical study, Bleeding on probing, Pus, Er:Yag laser, Ultrasonic device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcome assessor, in this case the dental hygienist performing the registrations/measurement, is blinded during the whole study The principal investigator, in this case the periodontologist performing all the treatments, and is therefore not blinded.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Er:Yag laser treatment
Arm Type
Experimental
Arm Description
The experimental (test) group will receive the following treatment: The submucosal debridement will be performed with an Er:Yag laser (AdvErL EVO, Morita Corporation, Japan). The P-400 tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.
Arm Title
Ultrasonic device treatment
Arm Type
Active Comparator
Arm Description
The active comparator (control) group will receive the following treatment: The submucosal debridement will be performed by a piezoelectric ultrasonic device with a PEEK coated tip (EMS, Switzerland). The tip is placed into the peri-implant mucositis pockets mesially, lingually, distally and buccally while rinsing water. Careful attempts are to cover the full circumference of the implant.
Intervention Type
Radiation
Intervention Name(s)
Er:Yag laser
Intervention Description
Submucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water.
Intervention Type
Device
Intervention Name(s)
EMS ultrasound
Intervention Description
Submucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water.
Primary Outcome Measure Information:
Title
Bleeding on probing (BOP)
Description
millimeter
Time Frame
Baseline
Title
Bleeding on probing (BOP)
Description
millimeter
Time Frame
1 month
Title
Bleeding on probing (BOP)
Description
millimeter
Time Frame
3 months
Title
Bleeding on probing (BOP)
Description
millimeter
Time Frame
6 months
Title
Probing pocket depth (PPD)
Description
millimeter
Time Frame
Baseline
Title
Probing pocket depth (PPD)
Description
millimeter
Time Frame
1 month
Title
Probing pocket depth (PPD)
Description
millimeter
Time Frame
3 months
Title
Probing pocket depth (PPD)
Description
millimeter
Time Frame
6 months
Title
Pus
Description
Presence or abscence
Time Frame
Baseline
Title
Pus
Description
Presence or abscence
Time Frame
1 month
Title
Pus
Description
Presence or abscence
Time Frame
3 months
Title
Pus
Description
Presence or abscence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recession of the peri-implant mucosal margin
Description
millimeter
Time Frame
Baseline
Title
Recession of the peri-implant mucosal margin
Description
millimeter
Time Frame
6 months
Title
Bone level (peri-apical radiographs)
Description
millimeter on Xray
Time Frame
Baseline
Title
Bone level (peri-apical radiographs)
Description
millimeter on Xray
Time Frame
6 months
Title
Implant loss
Description
Prevalence
Time Frame
Baseline
Title
Implant loss
Description
Prevalence
Time Frame
1 month
Title
Implant loss
Description
Prevalence
Time Frame
3 months
Title
Implant loss
Description
Prevalence
Time Frame
6 months
Title
Treatment time
Description
minutes
Time Frame
Baseline
Title
Treatment time
Description
minutes
Time Frame
3 months
Title
Treatment time
Description
minutes
Time Frame
6 months
Title
Quality of life (QoL)
Description
Questionnaire "Oral Health Impact Proflie" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)
Time Frame
Baseline
Title
Quality of life (QoL)
Description
Questionnaire "Oral Health Impact Profile" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Renvert, Prof
Organizational Affiliation
Kristianstad University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kristianstad
City
Kristianstad
ZIP/Postal Code
29893
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15330944
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.
Results Reference
background
PubMed Identifier
29926491
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.
Results Reference
background
PubMed Identifier
25495683
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.
Results Reference
background
PubMed Identifier
30133748
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.
Results Reference
background
PubMed Identifier
16634959
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.
Results Reference
background
PubMed Identifier
29926953
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.
Results Reference
background
PubMed Identifier
17219255
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.
Results Reference
background

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Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device

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