Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127228
• Other study ID #: HUM00124386
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: November 2, 2018

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• 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

Device:
• 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

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Morita J USA

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Gonçalves 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. — View Citation

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. — View Citation

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. — View Citation

Kreisler M, Kohnen W, Marinello C, Götz 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Renvert S, Roos-Jansåker 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. Review. — View Citation

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. — View Citation

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. — View Citation

Suárez-López 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. eCollection 2016 Jul-Sep. Review. — View Citation

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. Epub 2007 Jan 12. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	Baseline and 24 Week
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.	Baseline and 24 Week
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.	Baseline and 24 Week