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Peri-ImplantitisNCT04251793

Therapeutic Peri-implant Maintenance with Laser Therapy

An observational study of Peri-Implantitis, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study represents an extension of the previously concluded randomized clinical trial "Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis" (HUM00124386). Read more about this study

Who is it for?
Any age
Conditions the study is for
Peri-Implantitis
What is being tested?
Observation
How many people
16 participants
Where
1 siteUnited States
Study dates
8 Jul 2019to 2 Jun 2021
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects who previously participated in the Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis study HUM00124386.

Who may be able to join

  • Subjects who were previously enrolled subjects in the randomized clinical trial of laser-assisted regenerative surgical therapy

Who cannot join

  • Unable to reach the subject
  • The implant is mobile or lost
  • Premature Exclusion Criteria:
  • The researcher believes that it is not the best interest of the subject to stay in the study
  • If the subject becomes ineligible to participate based on the exclusion criteria
  • If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc.)
  • If the subject does not follow study related instructions
  • The study is suspended or canceled.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan School of Dentistry

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Therapeutic Peri-implant Maintenance with Laser Therapy: an Extension of the LARST Study

The present study represents an extension of the previously concluded randomized clinical trial "Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis" (HUM00124386). The aim of the study is to compare the adjunctive effect of laser over mechanical debridement alone in the maintenance of peri-implant tissues after surgical treatment of peri-implantitis (gum disease around implants).

Read the detailed description

The same 24 subjects, previously treated with surgical regenerative treatment of peri-implantitis following the LARST protocol, will be invited to return for three follow-up visits. During the follow-up visits, clinical measurements, x-rays, and pictures of the inside of their mouth will be taken to evaluate the success of their peri-implantitis treatment. If needed, additional laser treatment of the dental implant may also be provided according to the same randomization of subjects in the original study. No placebo laser application will be provided.

Being tested
Observation
Keywords
Laser
Medical subject headings
Peri-Implantitis

What participants receive

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

  • ObservationOther

    Soft tissue implant measurements and radiographs

Study groups in NCT04251793
Study groupRoleWhat they receive
Er:YAG laser-assisted debridementSubjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with the aid of the laser treatment two years ago at the Graduate Periodontics Clinic at University of Michigan.
Receives: Other: Observation
Standard mechanical debridementSubjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with dental scalers two years ago at the Graduate Periodontics Clinic at University of Michigan.
Receives: Other: Observation

What is being measured

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

  1. Change in Periodontal Probing Depths (PD)

    PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks

    Measured: Baseline and 6 months

Secondary outcomes (2)

  1. Change in Clinical Attachment Level (CAL)

    CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months.

    Measured: Baseline and 6 months

  2. Change in marginal bone level (MBL)

    Marginal bone level will be measured compared to baseline. Participants' standardized radiographs will be used to determine bone level changes between baseline and 6 months.

    Measured: Baseline and 6 months

Timeline

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

  1. First posted5 Feb 2020
  2. Study start8 Jul 2019
  3. Primary completion2 Jun 2021
  4. Study completion2 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04251793
Sponsor's protocol ID
HUM00160290
Status last verified
Jul 2021
First submitted
30 Jan 2020
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Al-Hashedi AA, Laurenti M, Benhamou V, Tamimi F. Decontamination of titanium implants using physical methods. Clin Oral Implants Res. 2017 Aug;28(8):1013-1021. doi: 10.1111/clr.12914. Epub 2016 Jul 8.

    PubMed 27392811

  • Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Spontaneous progression of ligatured induced peri-implantitis at implants with different surface characteristics. An experimental study in dogs II: histological observations. Clin Oral Implants Res. 2009 Apr;20(4):366-71. doi: 10.1111/j.1600-0501.2008.01645.x.

    PubMed 19309770

  • Berglundh T, Wennstrom JL, Lindhe J. Long-term outcome of surgical treatment of peri-implantitis. A 2-11-year retrospective study. Clin Oral Implants Res. 2018 Apr;29(4):404-410. doi: 10.1111/clr.13138. Epub 2018 Mar 25.

    PubMed 29575025

  • 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.

    PubMed 25495683

  • Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.

    PubMed 27335316

  • Isehed C, Svenson B, Lundberg P, Holmlund A. Surgical treatment of peri-implantitis using enamel matrix derivative, an RCT: 3- and 5-year follow-up. J Clin Periodontol. 2018 Jun;45(6):744-753. doi: 10.1111/jcpe.12894. Epub 2018 Apr 26.

    PubMed 29574866

  • Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.

    PubMed 24303954

  • 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.

    PubMed 30133748

  • Mizutani K, Aoki A, Coluzzi D, Yukna R, Wang CY, Pavlic V, Izumi Y. Lasers in minimally invasive periodontal and peri-implant therapy. Periodontol 2000. 2016 Jun;71(1):185-212. doi: 10.1111/prd.12123.

    PubMed 27045437

  • Renvert S, Lindahl C, Persson GR. Occurrence of cases with peri-implant mucositis or peri-implantitis in a 21-26 years follow-up study. J Clin Periodontol. 2018 Feb;45(2):233-240. doi: 10.1111/jcpe.12822. Epub 2017 Nov 29.

    PubMed 28963776

  • Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.

    PubMed 30328195

  • Roccuzzo M, Pittoni D, Roccuzzo A, Charrier L, Dalmasso P. Surgical treatment of peri-implantitis intrabony lesions by means of deproteinized bovine bone mineral with 10% collagen: 7-year-results. Clin Oral Implants Res. 2017 Dec;28(12):1577-1583. doi: 10.1111/clr.13028. Epub 2017 Jun 18.

    PubMed 28626970

  • Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.

    PubMed 29926957

  • Schwarz F, Hegewald A, John G, Sahm N, Becker J. Four-year follow-up of combined surgical therapy of advanced peri-implantitis evaluating two methods of surface decontamination. J Clin Periodontol. 2013 Oct;40(10):962-7. doi: 10.1111/jcpe.12143. Epub 2013 Aug 12.

    PubMed 23931259

  • Takagi T, Aoki A, Ichinose S, Taniguchi Y, Tachikawa N, Shinoki T, Meinzer W, Sculean A, Izumi Y. Effective removal of calcified deposits on microstructured titanium fixture surfaces of dental implants with erbium lasers. J Periodontol. 2018 Jun;89(6):680-690. doi: 10.1002/JPER.17-0389.

    PubMed 29536538

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis, run by University of Michigan at 1 site in United States.

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 1 inclusion and 8 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 12 Nov 2024. 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 United States. 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?

Change in Periodontal Probing Depths (PD) (time frame: Baseline and 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 NCT04251793, which also lists 16 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 12 Nov 2024.

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