Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty

NCT04259840 | Terminated

• 1 other identifier: HUM00169996
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the current study are 1) to assess the therapeutic resolution of the peri-implantitis after resective surgical treatment with or without implantoplasty procedure (no further radiographic bone loss, no erythema of the peri-implant mucosa, PD \<6mm), and 2) to evaluate the survival rate of the peri-implantitis treated dental implants.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (4)

• Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss

  The implant has no further radiographic bone loss when compared to previous radiographs.

  Up to 30 years after the implant was treated for peri-implantitis

• Therapeutic resolution of the peri-implantitis as measured by erythema

  The implant has no current erythema of the peri-implant mucosa.

  Up to 30 years after the implant was treated for peri-implantitis

• Therapeutic resolution of the peri-implantitis as measured by probing depths

  The implant has probing depths less than or equal to 5 millimeters.

  Up to 30 years after the implant was treated for peri-implantitis

• Survival rate of the peri-implantitis treated dental implants

  Survival rate will be determined by the duration of implant survival (functioning, non-symptomatic implant after peri-implantitis treatment).

  Up to 30 years after the implant was treated for peri-implantitis

Study Arms (1)

Peri-implantitis

Patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic from January 1, 1990 through July 1, 2018

Other: Observation

Interventions

Observation OTHER

Soft tissue implant measurements

Peri-implantitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic from January 1, 1990 through July 1, 2018

You may qualify if:

• The patient is at least 18 years of age,
• was initially diagnosed with peri-implantitis at ≥1 implant (peri-implant probing depth (PPD) ≥ 6 mm together with bleeding and/or suppuration on probing (BOP/SoP) and bone loss progression over physiological bone remodeling radiologically assessed or marginal bone loss ≥ 3 mm radiologically assessed in case of absence of baseline radiographs),
• had received treatment for peri-implantitis at least 1 year ago at the Graduate Clinic of Periodontics at University of Michigan, and
• documentation from ≥ 1 year of clinical and radiological follow- up is available from U of M patients records.

You may not qualify if:

• Has received or is currently receiving radiotherapy,
• are currently pregnant, unsure of their pregnancy status, or are lactating (as reported by the patient),
• has health condition(s) or takes medication(s) that are known to affect soft tissue or bone (e.g., Phenytoin)
• Received any kind of bone graft during the treatment of the peri-implantitis

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (22)

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.

  PMID: 29926955 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 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

• Englezos E, Cosyn J, Koole S, Jacquet W, De Bruyn H. Resective Treatment of Peri-implantitis: Clinical and Radiographic Outcomes After 2 Years. Int J Periodontics Restorative Dent. 2018 Sep/Oct;38(5):729-735. doi: 10.11607/prd.3386.

  PMID: 30113610 BACKGROUND

• Hammerle CHF, Tarnow D. The etiology of hard- and soft-tissue deficiencies at dental implants: A narrative review. J Clin Periodontol. 2018 Jun;45 Suppl 20:S267-S277. doi: 10.1111/jcpe.12955.

  PMID: 29926502 BACKGROUND

• Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x.

  PMID: 18724857 BACKGROUND

• Khoury F, Buchmann R. Surgical therapy of peri-implant disease: a 3-year follow-up study of cases treated with 3 different techniques of bone regeneration. J Periodontol. 2001 Nov;72(11):1498-508. doi: 10.1902/jop.2001.72.11.1498.

  PMID: 11759861 BACKGROUND

• Machtei EE. Treatment Alternatives to Negotiate Peri-Implantitis. Adv Med. 2014;2014:487903. doi: 10.1155/2014/487903. Epub 2014 Jun 15.

  PMID: 26556414 BACKGROUND

• Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.

  PMID: 30461016 BACKGROUND

• Monje A, Galindo-Moreno P, Tozum TF, Suarez-Lopez del Amo F, Wang HL. Into the Paradigm of Local Factors as Contributors for Peri-implant Disease: Short Communication. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):288-92. doi: 10.11607/jomi.4265.

  PMID: 27004275 BACKGROUND

• Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.

  PMID: 31087457 BACKGROUND

• Monje A, Wang HL, Nart J. Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study. J Periodontol. 2017 Oct;88(10):1030-1041. doi: 10.1902/jop.2017.170135. Epub 2017 May 26.

  PMID: 28548886 BACKGROUND

• Renvert S, Polyzois I, Claffey N. Surgical therapy for the control of peri-implantitis. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:84-94. doi: 10.1111/j.1600-0501.2012.02554.x.

  PMID: 23062132 BACKGROUND

• Rimondini L, Fare S, Brambilla E, Felloni A, Consonni C, Brossa F, Carrassi A. The effect of surface roughness on early in vivo plaque colonization on titanium. J Periodontol. 1997 Jun;68(6):556-62. doi: 10.1902/jop.1997.68.6.556.

  PMID: 9203099 BACKGROUND

• Roccuzzo M, De Angelis N, Bonino L, Aglietta M. Ten-year results of a three-arm prospective cohort study on implants in periodontally compromised patients. Part 1: implant loss and radiographic bone loss. Clin Oral Implants Res. 2010 May;21(5):490-6. doi: 10.1111/j.1600-0501.2009.01886.x. Epub 2010 Mar 11.

  PMID: 20337668 BACKGROUND

• Romeo E, Ghisolfi M, Murgolo N, Chiapasco M, Lops D, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part I: clinical outcome. Clin Oral Implants Res. 2005 Feb;16(1):9-18. doi: 10.1111/j.1600-0501.2004.01084.x.

  PMID: 15642026 BACKGROUND

• Romeo E, Lops D, Chiapasco M, Ghisolfi M, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part II: radiographic outcome. Clin Oral Implants Res. 2007 Apr;18(2):179-87. doi: 10.1111/j.1600-0501.2006.01318.x.

  PMID: 17348882 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, Sahm N, Becker J. Combined surgical therapy of advanced peri-implantitis lesions with concomitant soft tissue volume augmentation. A case series. Clin Oral Implants Res. 2014 Jan;25(1):132-6. doi: 10.1111/clr.12103. Epub 2013 Jan 27.

  PMID: 23350647 BACKGROUND

• Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24.

  PMID: 20374416 BACKGROUND

• Zitzmann NU, Berglundh T. Definition and prevalence of peri-implant diseases. J Clin Periodontol. 2008 Sep;35(8 Suppl):286-91. doi: 10.1111/j.1600-051X.2008.01274.x.

  PMID: 18724856 BACKGROUND

• Ravida A, Siqueira R, Saleh I, Saleh MHA, Giannobile A, Wang HL. Lack of Clinical Benefit of Implantoplasty to Improve Implant Survival Rate. J Dent Res. 2020 Nov;99(12):1348-1355. doi: 10.1177/0022034520944158. Epub 2020 Jul 27.

  PMID: 32718212 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Hom-Lay Wang, DDS MSD PhD

  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: Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 7, 2020
• Study Start: December 5, 2019
• Primary Completion: March 10, 2020
• Study Completion: July 1, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

US (1)