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

Peri-implant Mucositis Clinical Trial

Official title:

Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772299
• Other study ID #: P-I mucositis
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: August 17, 2023

Study information

• Verified date: October 2023
• Source: Kristianstad University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Radiation:
• Er:Yag laser
Submucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water.

Device:
• EMS ultrasound
Submucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water.

Locations

Country	Name	City	State
Sweden	University of Kristianstad	Kristianstad

Sponsors (1)

Lead Sponsor	Collaborator
Kristianstad University

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing (BOP)	millimeter	Baseline
Primary	Bleeding on probing (BOP)	millimeter	1 month
Primary	Bleeding on probing (BOP)	millimeter	3 months
Primary	Bleeding on probing (BOP)	millimeter	6 months
Primary	Probing pocket depth (PPD)	millimeter	Baseline
Primary	Probing pocket depth (PPD)	millimeter	1 month
Primary	Probing pocket depth (PPD)	millimeter	3 months
Primary	Probing pocket depth (PPD)	millimeter	6 months
Primary	Pus	Presence or abscence	Baseline
Primary	Pus	Presence or abscence	1 month
Primary	Pus	Presence or abscence	3 months
Primary	Pus	Presence or abscence	6 months
Secondary	Recession of the peri-implant mucosal margin	millimeter	Baseline
Secondary	Recession of the peri-implant mucosal margin	millimeter	6 months
Secondary	Bone level (peri-apical radiographs)	millimeter on Xray	Baseline
Secondary	Bone level (peri-apical radiographs)	millimeter on Xray	6 months
Secondary	Implant loss	Prevalence	Baseline
Secondary	Implant loss	Prevalence	1 month
Secondary	Implant loss	Prevalence	3 months
Secondary	Implant loss	Prevalence	6 months
Secondary	Treatment time	minutes	Baseline
Secondary	Treatment time	minutes	3 months
Secondary	Treatment time	minutes	6 months
Secondary	Quality of life (QoL)	Questionnaire "Oral Health Impact Proflie" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)	Baseline
Secondary	Quality of life (QoL)	Questionnaire "Oral Health Impact Profile" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)	6 months