Therapeutic Peri-implant Maintenance With Laser Therapy

• ClinicalTrials.gov Identifier: NCT04251793
• Recruitment Status: Enrolling by invitation
• First Posted: February 5, 2020
• Last Update Posted: December 22, 2020
• Sponsor: University of Michigan
• Collaborator: Morita J USA
• Information provided by (Responsible Party): Chin-Wei Wang, University of Michigan

Tracking Information

• First Submitted Date: January 30, 2020
• First Posted Date: February 5, 2020
• Last Update Posted Date: December 22, 2020
• Actual Study Start Date: July 8, 2019
• Estimated Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2020)

Change in Periodontal Probing Depths (PD) [ Time Frame: Baseline and 6 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 30, 2020)

• Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline and 6 months ]
  CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months.
• Change in marginal bone level (MBL) [ Time Frame: Baseline and 6 months ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Therapeutic Peri-implant Maintenance With Laser Therapy
• Official Title: Therapeutic Peri-implant Maintenance With Laser Therapy: An Extension of the LARST Study
• 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).
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Subjects who previously participated in the Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis study HUM00124386.
• Condition: Peri-Implantitis

Intervention

Other: Observation

Soft tissue implant measurements and radiographs

Study Groups/Cohorts

• 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.
  Intervention: 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.
  Intervention: Other: Observation

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.
• 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.
• Berglundh T, Wennström 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.
• 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. Review.
• 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.
• 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.
• 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.
• Lin GH, Suárez López 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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. Review.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: January 30, 2020): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2021
• Estimated Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04251793
• Other Study ID Numbers: HUM00160290
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Chin-Wei Wang, University of Michigan
• Study Sponsor: University of Michigan
• Collaborators: Morita J USA

Investigators

• Principal Investigator: Chin-Wei Wang, DDS, DMSc; Department of Periodontics and Oral Medicine University of Michigan

• PRS Account: University of Michigan
• Verification Date: December 2020