Therapeutic Peri-implant Maintenance with Laser Therapy

NCT ID: NCT04251793

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-08

Study Completion Date

2021-06-02

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Peri-Implantitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Er:YAG laser-assisted debridement

Subjects 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.

Observation

Intervention Type OTHER

Soft tissue implant measurements and radiographs

Standard mechanical debridement

Subjects 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.

Observation

Intervention Type OTHER

Soft tissue implant measurements and radiographs

Interventions

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Observation

Soft tissue implant measurements and radiographs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to reach the subject
* The implant is mobile or lost


* The researcher believes that it is not the best interest of the subject to stay in the study
* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Morita J USA

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Chin-Wei Wang

Clinical Assistant Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Wei Wang, DDS, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontics and Oral Medicine University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27392811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19309770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29575025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25495683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27335316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29574866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24303954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30133748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27045437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28963776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30328195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28626970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29926957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23931259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29536538 (View on PubMed)

Wang HL, Garaicoa-Pazmino C, Collins A, Ong HS, Chudri R, Giannobile WV. Protein biomarkers and microbial profiles in peri-implantitis. Clin Oral Implants Res. 2016 Sep;27(9):1129-36. doi: 10.1111/clr.12708. Epub 2015 Oct 1.

Reference Type BACKGROUND
PMID: 26424287 (View on PubMed)

Other Identifiers

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HUM00160290

Identifier Type: -

Identifier Source: org_study_id

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