Peri-implant MucositisNCT05772299
Treatment of Inflammation Around Implants With a Laser or an Ultrasonic Device
A study testing Er:Yag laser and EMS ultrasound in people with Peri-implant Mucositis, run by Kristianstad University at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 23 to 100 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Er:Yag laser and EMS ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2021to 17 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- Subjects with uncontrolled diabetes HbA1c >6.5
- Subjects requiring prophylactic antibiotics
- Subjects taking prednisolone
- Subjects taking medications known to have effects on gingival overgrowth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Peri-implant Mucositis
- Being tested
- Er:Yag laser, EMS ultrasound
- Keywords
- Clinical study, Bleeding on probing, Pus, Er:Yag laser, Ultrasonic device
- Medical subject headings
- Suppuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:Yag laserRadiation
Submucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water.
EMS ultrasoundDevice
Submucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water.
| Study group | Role | What they receive |
|---|---|---|
| Er:Yag laser treatment | Experimental | 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. Receives: Radiation: Er:Yag laser |
| Ultrasonic device treatment | Active comparator | 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. Receives: Device: EMS ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP)
millimeter
Measured: Baseline
Bleeding on probing (BOP)
millimeter
Measured: 1 month
Bleeding on probing (BOP)
millimeter
Measured: 3 months
Bleeding on probing (BOP)
millimeter
Measured: 6 months
Probing pocket depth (PPD)
millimeter
Measured: Baseline
Probing pocket depth (PPD)
millimeter
Measured: 1 month
Probing pocket depth (PPD)
millimeter
Measured: 3 months
Probing pocket depth (PPD)
millimeter
Measured: 6 months
Pus
Presence or abscence
Measured: Baseline
Pus
Presence or abscence
Measured: 1 month
Pus
Presence or abscence
Measured: 3 months
Pus
Presence or abscence
Measured: 6 months
Secondary outcomes (13)
Recession of the peri-implant mucosal margin
millimeter
Measured: Baseline
Recession of the peri-implant mucosal margin
millimeter
Measured: 6 months
Bone level (peri-apical radiographs)
millimeter on Xray
Measured: Baseline
Bone level (peri-apical radiographs)
millimeter on Xray
Measured: 6 months
Implant loss
Prevalence
Measured: Baseline
Implant loss
Prevalence
Measured: 1 month
Implant loss
Prevalence
Measured: 3 months
Implant loss
Prevalence
Measured: 6 months
Treatment time
minutes
Measured: Baseline
Treatment time
minutes
Measured: 3 months
Treatment time
minutes
Measured: 6 months
Quality of life (QoL)
Questionnaire "Oral Health Impact Proflie" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)
Measured: Baseline
Quality of life (QoL)
Questionnaire "Oral Health Impact Profile" (OHIP-14) on a 5 -point Likert scale 0=never (best) ; 5=very often (worst)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start31 Aug 2021
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristianstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viveca Wallin Bengtsson, Kristianstad University
- Investigators
- Stefan Renvert, Prof, Principal investigator, Kristianstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772299
- Sponsor's protocol ID
- P-I mucositis
- Status last verified
- Oct 2023
- First submitted
- 6 Mar 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15330944Berglundh 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.
PubMed 29926491Derks 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.
PubMed 25495683Lin 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.
PubMed 30133748Renvert 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.
PubMed 16634959Renvert 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.
PubMed 29926953Takasaki 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.
PubMed 17219255Bengtsson VW, Aoki A, Mizutani K, Lindahl C, Renvert S. Treatment of peri-implant mucositis using an Er:YAG laser or an ultrasonic device: a randomized, controlled clinical trial. Int J Implant Dent. 2025 Jan 24;11(1):6. doi: 10.1186/s40729-025-00591-0.
PubMed 39853624
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05772299
- Acronym / sponsor ID
- P-I mucositis
- Conditions
- Peri-implant Mucositis
- Keywords
- Clinical study, Bleeding on probing, Pus, Er:Yag laser, Ultrasonic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kristianstad UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Er:Yag laser treatment | Experimental | Radiation: Er:Yag laserThe 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. |
| Ultrasonic device treatment | Active comparator | Device: EMS ultrasoundThe 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. |
Who may qualify
- Ages
- 23 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- Subjects with uncontrolled diabetes HbA1c >6.5
- Subjects requiring prophylactic antibiotics
- Subjects taking prednisolone
- Subjects taking medications known to have effects on gingival overgrowth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Er:Yag laserSubmucosal debridement is performed with Er:Yag laser using a P-400 tip under rinsing water. | Radiation | Er:Yag laser treatment |
| EMS ultrasoundSubmucosal debridement is performed with piezoelectric ultrasound (EMS) with a PEEK (plastic coated) tip under rinsing water. | Device | Ultrasonic device treatment |
Primary outcome
Bleeding on probing (BOP)
Time frame: Baseline
millimeter
Bleeding on probing (BOP)
Time frame: 1 month
millimeter
Bleeding on probing (BOP)
Time frame: 3 months
millimeter
Bleeding on probing (BOP)
Time frame: 6 months
millimeter
Probing pocket depth (PPD)
Time frame: Baseline
millimeter
Probing pocket depth (PPD)
Time frame: 1 month
millimeter
Probing pocket depth (PPD)
Time frame: 3 months
millimeter
Probing pocket depth (PPD)
Time frame: 6 months
millimeter
Pus
Time frame: Baseline
Presence or abscence
Pus
Time frame: 1 month
Presence or abscence
Pus
Time frame: 3 months
Presence or abscence
Pus
Time frame: 6 months
Presence or abscence
13 secondary outcomes
Recession of the peri-implant mucosal margin
Time frame: Baseline
Recession of the peri-implant mucosal margin
Time frame: 6 months
Bone level (peri-apical radiographs)
Time frame: Baseline
Bone level (peri-apical radiographs)
Time frame: 6 months
Implant loss
Time frame: Baseline
Implant loss
Time frame: 1 month
Implant loss
Time frame: 3 months
Implant loss
Time frame: 6 months
Treatment time
Time frame: Baseline
Treatment time
Time frame: 3 months
Treatment time
Time frame: 6 months
Quality of life (QoL)
Time frame: Baseline
Quality of life (QoL)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 15330944Aoki 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.
- Background: PubMed 29926491Berglundh 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.
- Background: PubMed 25495683Derks 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.
- Background: PubMed 30133748Lin 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.
- Background: PubMed 16634959Renvert 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.
- Background: PubMed 29926953Renvert 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.
- Background: PubMed 17219255Takasaki 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.
- Derived from this study: PubMed 39853624Bengtsson VW, Aoki A, Mizutani K, Lindahl C, Renvert S. Treatment of peri-implant mucositis using an Er:YAG laser or an ultrasonic device: a randomized, controlled clinical trial. Int J Implant Dent. 2025 Jan 24;11(1):6. doi: 10.1186/s40729-025-00591-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Renvert, Prof principal investigator
Kristianstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:Yag laser and EMS ultrasound in people with Peri-implant Mucositis, run by Kristianstad University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BOP) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772299, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.