Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

NCT03127228 | Completed Results FDA Device

• 1 other identifier: HUM00124386
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.

Conditions

Peri-Implantitis

Keywords

Laser

Outcome Measures

Primary Outcomes (4)

• 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 24 Week

• Change in Clinical Attachment Level (CAL)

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

  Baseline and 24 Week

• Change in Bleeding on Probing (BOP)

  BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.

  Baseline and 24 Week

• Change in Radiographic Bone Fill (RBF)

  Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.

  Baseline and 24 Week

Study Arms (2)

Standard mechanical debridement

OTHER

Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.

Other: Standard mechanical debridement

Er:YAG laser-assisted debridement

EXPERIMENTAL

Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.

Other: Standard mechanical debridement; Device: Er:YAG laser-assisted debridement

Interventions

Standard mechanical debridement OTHER

Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy

Er:YAG laser-assisted debridement; Standard mechanical debridement

Er:YAG laser-assisted debridement DEVICE

Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy

Er:YAG laser-assisted debridement

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, aged 18 - 85 years
• Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
• Subjects having a minimum of 1 dental implant with peri-implantitis.
• Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus)
• The implants are in function for at least 6 months
• Only rough surface implant will be included in this study

You may not qualify if:

• Long-term use of antibiotics \> 2 weeks in the past two months
• Obvious malpositioning of the dental implants
• Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate)
• Pregnant females or those planning to become pregnant
• Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
• Mobility of dental implants
• History of alcoholism or drug abuse
• Current smokers
• Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>8)
• Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease
• 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, 48104, United States

Location

Related Publications (25)

• Aljateeli M, Fu JH, Wang HL. Managing peri-implant bone loss: current understanding. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e109-18. doi: 10.1111/j.1708-8208.2011.00387.x. Epub 2011 Oct 10.

  PMID: 21985674 BACKGROUND

• Aoki A, Mizutani K, Schwarz F, Sculean A, Yukna RA, Takasaki AA, Romanos GE, Taniguchi Y, Sasaki KM, Zeredo JL, Koshy G, Coluzzi DJ, White JM, Abiko Y, Ishikawa I, Izumi Y. Periodontal and peri-implant wound healing following laser therapy. Periodontol 2000. 2015 Jun;68(1):217-69. doi: 10.1111/prd.12080.

  PMID: 25867988 BACKGROUND

• Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.

  PMID: 23237585 BACKGROUND

• Claffey N, Clarke E, Polyzois I, Renvert S. Surgical treatment of peri-implantitis. J Clin Periodontol. 2008 Sep;35(8 Suppl):316-32. doi: 10.1111/j.1600-051X.2008.01277.x.

  PMID: 18724859 BACKGROUND

• De Bruyn H, Vandeweghe S, Ruyffelaert C, Cosyn J, Sennerby L. Radiographic evaluation of modern oral implants with emphasis on crestal bone level and relevance to peri-implant health. Periodontol 2000. 2013 Jun;62(1):256-70. doi: 10.1111/prd.12004.

  PMID: 23574471 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

• Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. doi: 10.1111/j.1600-0501.2005.01137.x.

  PMID: 16117768 BACKGROUND

• Goncalves F, Zanetti AL, Zanetti RV, Martelli FS, Avila-Campos MJ, Tomazinho LF, Granjeiro JM. Effectiveness of 980-mm diode and 1064-nm extra-long-pulse neodymium-doped yttrium aluminum garnet lasers in implant disinfection. Photomed Laser Surg. 2010 Apr;28(2):273-80. doi: 10.1089/pho.2009.2496.

  PMID: 19811080 BACKGROUND

• Jensen MP, Karoly P, O'Riordan EF, Bland F Jr, Burns RS. The subjective experience of acute pain. An assessment of the utility of 10 indices. Clin J Pain. 1989 Jun;5(2):153-9. doi: 10.1097/00002508-198906000-00005.

  PMID: 2520397 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

• Kreisler M, Kohnen W, Marinello C, Gotz H, Duschner H, Jansen B, d'Hoedt B. Bactericidal effect of the Er:YAG laser on dental implant surfaces: an in vitro study. J Periodontol. 2002 Nov;73(11):1292-8. doi: 10.1902/jop.2002.73.11.1292.

  PMID: 12479633 BACKGROUND

• Marrone A, Lasserre J, Bercy P, Brecx MC. Prevalence and risk factors for peri-implant disease in Belgian adults. Clin Oral Implants Res. 2013 Aug;24(8):934-40. doi: 10.1111/j.1600-0501.2012.02476.x. Epub 2012 May 3.

  PMID: 22551347 BACKGROUND

• Matys J, Dominiak M. Assessment of Pain When Uncovering Implants with Er:YAG Laser or Scalpel for Second Stage Surgery. Adv Clin Exp Med. 2016 Nov-Dec;25(6):1179-1184. doi: 10.17219/acem/62456.

  PMID: 28028971 BACKGROUND

• Nevins M, Nevins ML, Yamamoto A, Yoshino T, Ono Y, Wang CW, Kim DM. Use of Er:YAG laser to decontaminate infected dental implant surface in preparation for reestablishment of bone-to-implant contact. Int J Periodontics Restorative Dent. 2014 Jul-Aug;34(4):461-6. doi: 10.11607/prd.2192.

  PMID: 25006763 BACKGROUND

• Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.

  PMID: 23537178 BACKGROUND

• Quaranta A, Maida C, Scrascia A, Campus G, Quaranta M. Er:Yag Laser application on titanium implant surfaces contaminated by Porphyromonas gingivalis: an histomorphometric evaluation. Minerva Stomatol. 2009 Jul-Aug;58(7-8):317-30. English, Italian.

  PMID: 19633633 BACKGROUND

• Renvert S, Roos-Jansaker AM, Claffey N. Non-surgical treatment of peri-implant mucositis and peri-implantitis: a literature review. J Clin Periodontol. 2008 Sep;35(8 Suppl):305-15. doi: 10.1111/j.1600-051X.2008.01276.x.

  PMID: 18724858 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

• Schwarz F, Sahm N, Iglhaut G, Becker J. Impact of the method of surface debridement and decontamination on the clinical outcome following combined surgical therapy of peri-implantitis: a randomized controlled clinical study. J Clin Periodontol. 2011 Mar;38(3):276-84. doi: 10.1111/j.1600-051X.2010.01690.x. Epub 2011 Jan 11.

  PMID: 21219392 BACKGROUND

• Suarez-Lopez Del Amo F, Yu SH, Wang HL. Non-Surgical Therapy for Peri-Implant Diseases: a Systematic Review. J Oral Maxillofac Res. 2016 Sep 9;7(3):e13. doi: 10.5037/jomr.2016.7313. eCollection 2016 Jul-Sep.

  PMID: 27833738 BACKGROUND

• Takasaki AA, Aoki A, Mizutani K, Kikuchi S, Oda S, Ishikawa I. Er:YAG laser therapy for peri-implant infection: a histological study. Lasers Med Sci. 2007 Sep;22(3):143-57. doi: 10.1007/s10103-006-0430-x. Epub 2007 Jan 12.

  PMID: 17219255 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

• Yamamoto A, Tanabe T. Treatment of peri-implantitis around TiUnite-surface implants using Er:YAG laser microexplosions. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):21-30. doi: 10.11607/prd.1593.

  PMID: 23342343 BACKGROUND

• Wang CW, Di Gianfilippo R, Kaciroti N, Ou A, Feng SW, Wang HL. Stability of peri-implantitis surgical reconstructive therapy-a (> 2 years) follow-up of a randomized clinical trial. Clin Oral Investig. 2023 Dec 26;28(1):30. doi: 10.1007/s00784-023-05457-6.

  PMID: 38147180 DERIVED

• Wang CW, Ashnagar S, Gianfilippo RD, Arnett M, Kinney J, Wang HL. Laser-assisted regenerative surgical therapy for peri-implantitis: A randomized controlled clinical trial. J Periodontol. 2021 Mar;92(3):378-388. doi: 10.1002/JPER.20-0040. Epub 2020 Aug 25.

  PMID: 32761810 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Chin-Wei Wang
• Organization: University of Michigan

jeffwa@umich.edu

734-763-2105

Study Officials

• Jeff (Chin-Wei) Wang, DDS, DMSc

  Department of Periodontics and Oral Medicine University of Michigan School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 25, 2017
• Study Start: June 26, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: November 15, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

US (1)