Therapeutic Peri-implant Maintenance with Laser Therapy

NCT04251793 | Completed

• 1 other identifier: HUM00160290
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Peri-Implantitis

Keywords

Laser

Outcome Measures

Primary Outcomes (1)

• Change in Periodontal Probing Depths (PD)

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

  Baseline and 6 months

Secondary Outcomes (2)

• Change in Clinical Attachment Level (CAL)

  Baseline and 6 months

• Change in marginal bone level (MBL)

  Baseline and 6 months

Study Arms (2)

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.

Other: Observation

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.

Other: Observation

Interventions

Observation OTHER

Soft tissue implant measurements and radiographs

Er:YAG laser-assisted debridement; Standard mechanical debridement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Morita J USA: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (16)

• 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.

  PMID: 27392811 BACKGROUND

• 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.

  PMID: 19309770 BACKGROUND

• 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.

  PMID: 29575025 BACKGROUND

• 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.

  PMID: 25495683 BACKGROUND

• 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.

  PMID: 27335316 BACKGROUND

• 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.

  PMID: 29574866 BACKGROUND

• 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.

  PMID: 24303954 BACKGROUND

• 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.

  PMID: 30133748 BACKGROUND

• 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.

  PMID: 27045437 BACKGROUND

• 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.

  PMID: 28963776 BACKGROUND

• 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.

  PMID: 30328195 BACKGROUND

• 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.

  PMID: 28626970 BACKGROUND

• 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.

  PMID: 29926957 BACKGROUND

• 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.

  PMID: 23931259 BACKGROUND

• 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.

  PMID: 29536538 BACKGROUND

• 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.

  PMID: 26424287 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Chin-Wei Wang, DDS, DMSc

  Department of Periodontics and Oral Medicine University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Dentistry

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: July 8, 2019
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: November 12, 2024

Record last verified: 2021-07

Locations

US (1)