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Peri-ImplantitisNCT03819075

Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis

A study testing Lightwalker Laser (Fotona) and standard in people with Peri-Implantitis, run by Luis Monteiro at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peri-Implantitis
What is being tested?
Lightwalker Laser (Fotona) and standard
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 sitePortugal
Study dates
3 Mar 2018to May 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • at least one implant with peri-implantitis
  • no serious mobility of the implants
  • written informed consent of the voluntary participant in the study
  • availability of participant for control visits for a follow-up of at least 12 months without interruptions

Who cannot join

  • serious systematic disease
  • pregnancy
  • current use of photosensitive drugs, bisphosphonate medication or antibiotics
  • patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits

Trial locations and contacts

1 site in 1 country.

Luis Monteiro, DMD, PhD contact

+351 919120226

luis.monteiro@iucs.cespu.pt

Portugal1 site, 1 recruiting

  • Instituto Universitário de Ciências da Saude, CESPU

    Porto, 4585-116

    Luis Monteiro, +351 919120226, luis.monteiro@iucs.cespu.pt

    Recruiting

Other trials in Portugal

About this study

Official title: An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial

A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.

Read the detailed description

The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.

Being tested
Lightwalker Laser (Fotona), standard
Keywords
laser, Er:YAG, Nd:YAG, periimplantitis, randomized controlled trial
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lightwalker Laser (Fotona)Device

    Also called TwinLight periimplantitis

    For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.

  • standardOther

    Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.

Study groups in NCT03819075
Study groupRoleWhat they receive
LaserExperimentalFor the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.
Receives: Device: Lightwalker Laser (Fotona)
ControlActive comparatorStandard periimplantitis treatment will be conducted in the control group.
Receives: Other: standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with treatment success

    Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.

    Measured: 6 months

Secondary outcomes (25)

  1. Plaque index

    (PI)

    Measured: 1 month

  2. Plaque index

    (PI)

    Measured: 3 months

  3. Plaque index

    (PI)

    Measured: 6 months

  4. Plaque index

    (PI)

    Measured: 12 months

  5. Bleeding on probing

    (BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.

    Measured: 1 month

  6. Bleeding on probing

    evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.

    Measured: 3 months

  7. Bleeding on probing

    evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.

    Measured: 6 months

  8. Bleeding on probing

    evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.

    Measured: 12 months

  9. Probing depth

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 1 month

  10. Probing depth

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 3 months

  11. Probing depth

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 6 months

  12. Probing depth

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 12 months

  13. Mucosal recession

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 1 month

  14. Mucosal recession

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 3 months

  15. Mucosal recession

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 6 months

  16. Mucosal recession

    measured from the mucosal margin to the bottom of the pocket.

    Measured: 12 months

  17. Clinical attachment level gain

    Difference in clinical attachment level at baseline and follow up.

    Measured: 1 month

  18. Clinical attachment level gain

    Difference in clinical attachment level at baseline and follow up.

    Measured: 3 months

  19. Clinical attachment level gain

    Difference in clinical attachment level at baseline and follow up.

    Measured: 6 months

  20. Clinical attachment level gain

    Difference in clinical attachment level at baseline and follow up.

    Measured: 12 months

  21. Quality of life questionnaire

    Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.

    Measured: 0 months

  22. Quality of life questionnaire

    Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.

    Measured: 1 month

  23. Quality of life questionnaire

    Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.

    Measured: 3 months

  24. Quality of life questionnaire

    Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.

    Measured: 6 months

  25. Quality of life questionnaire

    Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start3 Mar 2018
  3. Primary completionDec 2023 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

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
Two groups; laser and control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03819075
Sponsor's protocol ID
26/CE-IUCS/2018
Status last verified
Aug 2023
First submitted
25 Jan 2019
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lightwalker Laser (Fotona) and standard in people with Peri-Implantitis, run by Luis Monteiro at 1 site in Portugal.

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 4 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: status not confirmed, as of the sponsor's last update on 1 Sep 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 Portugal. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luis Monteiro, DMD, PhD (+351 919120226, luis.monteiro@iucs.cespu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with treatment success (time frame: 6 months). 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 NCT03819075.

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 1 Sep 2023.

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