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| Name | Class |
|---|---|
| Morita J USA | UNKNOWN |
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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.
The purpose of the study is to evaluate if using 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.
This study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit.
Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy
Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile
Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard mechanical debridement | Other | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Premature Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff (Chin-Wei) Wang, DDS, DMSc | Department of Periodontics and Oral Medicine University of Michigan School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21985674 | Background | 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. | |
| 25867988 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Mechanical Debridement | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy |
| FG001 | Er:YAG Laser-assisted Debridement | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment. Standard mechanical debridement: 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: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Mechanical Debridement | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Periodontal Probing Depths (PD) | PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks. | Posted | Mean | Standard Deviation | millimeters | Baseline and 24 Week | Implants | Implants |
|
6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Mechanical Debridement | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | During medical/dental history update participant reported having a sinus tract infection. Dispensed antibiotics and referred participant to their primary care physician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chin-Wei Wang | University of Michigan | 734-763-2105 | jeffwa@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Oct 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|
| 23237585 | 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. |
| 18724859 | 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. |
| 23574471 | 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. |
| 25495683 | 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. |
| 16117768 | 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. |
| 19811080 | 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. |
| 2520397 | 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. |
| 24303954 | 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. |
| 12479633 | 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. |
| 22551347 | 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. |
| 28028971 | 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. |
| 25006763 | 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. |
| 23537178 | 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. |
| 19633633 | 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. |
| 18724858 | 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. |
| 23931259 | 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. |
| 21219392 | 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. |
| 27833738 | 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. |
| 17219255 | 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. |
| 26424287 | 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. |
| 23342343 | 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. |
| 38147180 | Derived | 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. |
| 32761810 | 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. |
| BG001 |
| Er:YAG Laser-assisted Debridement |
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment. Standard mechanical debridement: 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: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Clinical Attachment Level (CAL) | CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks. | Posted | Mean | Standard Deviation | millimeters | Baseline and 24 Week | Implants | Implants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of sites with BOP | Baseline and 24 Week | Implants | Implants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Millimeters | Baseline and 24 Week | Implants | Implants |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Er:YAG Laser-assisted Debridement | Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment. Standard mechanical debridement: 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: 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 | 0 | 12 | 0 | 12 | 3 | 12 |
|
| Tooth pain | General disorders | Systematic Assessment | Participant reported tooth pain in lower right quadrant of his mouth. This was a non-study tooth. Participant was referred to his general dentist for care. |
|
| Flu | Infections and infestations | Systematic Assessment | Participant reported having the flu and currently taking antibiotics. |
|
| Jaw discomfort | General disorders | Systematic Assessment | Participant reported having jaw discomfort in both of his jaw joints. Participant was currently being treated by his general dentist. |
|
| Broken filling | General disorders | Systematic Assessment | Participant reported having a broken filling on a non-study tooth. Participant had an appointment scheduled with their general dentist for care. |
|
| Shoulder Pain | Injury, poisoning and procedural complications | Systematic Assessment | During medical and dental history update the participant reported to have fallen on her shoulder and went to see her primary care physician for treatment. |
|
| Fistula | Infections and infestations | Systematic Assessment | Participant reported having a "water bubble" on the inside of his lower left molar. Upon examination it was determined that the participant could have a root canal infection. Participant was referred to a root canal specialist for treatment. |
|
| Ulcer on ear | Ear and labyrinth disorders | Systematic Assessment | During the oral exam it was noticed that the participant had an ulcer on his right ear. Participant was referred to this primary care physician for care. |
|
| Residual suture | General disorders | Systematic Assessment | Participant reported that there was a residual suture in his mouth. Suture was removed. |
|
| Shingles | Immune system disorders | Systematic Assessment | Participant reported that he had shingles and was being treated by his primary care physician. |
|
| Crown off | General disorders | Systematic Assessment | Participant reported that the crown fell off of his tooth (non-study tooth). Participant was referred to general dentist for treatment. |
|
| Type 2 Diabetes | Immune system disorders | Systematic Assessment | During medical/dental history review the participant reported to have recently been diagnosed with type 2 diabetes. |
|
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