Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

NCT03772652 | Terminated

• 1 other identifier: HUM00148346
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on evaluating the success of different treatment methods for peri-implantitis (gum disease around implants) and to understand the factors that might affect the success of the treatment provided.

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.

  At least five 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.

  At least five 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.

  At least five 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).

  At least five years after the implant was treated for peri-implantitis

Study Arms (1)

Peri-implantitis

Subjects who were diagnosed with peri-implantitis and received treatment at least five years ago at the Graduate Periodontics Clinic at University of Michigan with sufficient baseline data. Soft tissue measurements (observation) of the implant will be completed.

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

Subjects who were diagnosed with peri-implantitis and received treatment at least 5 years ago.

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 radiologically assessed marginal bone loss ≥ 3 mm),
• had received treatment for peri-implantitis at least 5 years ago at the Graduate Clinic of Periodontics at University of Michigan, and
• documentation from ≥ 5 years 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (25)

• 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

• Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.

  PMID: 18724855 BACKGROUND

• Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x.

  PMID: 21323713 BACKGROUND

• Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x.

  PMID: 22533957 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

• Mombelli A, Muller N, Cionca N. The epidemiology of peri-implantitis. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:67-76. doi: 10.1111/j.1600-0501.2012.02541.x.

  PMID: 23062130 BACKGROUND

• Kotsovilis S, Karoussis IK, Trianti M, Fourmousis I. Therapy of peri-implantitis: a systematic review. J Clin Periodontol. 2008 Jul;35(7):621-9. doi: 10.1111/j.1600-051X.2008.01240.x. Epub 2008 May 11.

  PMID: 18476998 BACKGROUND

• Klokkevold PR, Han TJ. How do smoking, diabetes, and periodontitis affect outcomes of implant treatment? Int J Oral Maxillofac Implants. 2007;22 Suppl:173-202.

  PMID: 18437796 BACKGROUND

• Canullo L, Penarrocha M, Monje A, Catena A, Wang HL, Penarrocha D. Association Between Clinical and Microbiologic Cluster Profiles and Peri-implantitis. Int J Oral Maxillofac Implants. 2017 Sep/Oct;32(5):1054-1064. doi: 10.11607/jomi.6043.

  PMID: 28906504 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

• 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

• 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

• Wiltfang J, Zernial O, Behrens E, Schlegel A, Warnke PH, Becker ST. Regenerative treatment of peri-implantitis bone defects with a combination of autologous bone and a demineralized xenogenic bone graft: a series of 36 defects. Clin Implant Dent Relat Res. 2012 Jun;14(3):421-7. doi: 10.1111/j.1708-8208.2009.00264.x. Epub 2010 Feb 3.

  PMID: 20132246 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

• Li X, Wang X, Zhao T, Gao B, Miao Y, Zhang D, Dong Y. Guided bone regeneration using chitosan-collagen membranes in dog dehiscence-type defect model. J Oral Maxillofac Surg. 2014 Feb;72(2):304.e1-14. doi: 10.1016/j.joms.2013.09.042. Epub 2013 Oct 9.

  PMID: 24438600 BACKGROUND

• Schou S, Holmstrup P, Skovgaard LT, Stoltze K, Hjorting-Hansen E, Gundersen HJ. Autogenous bone graft and ePTFE membrane in the treatment of peri-implantitis. II. Stereologic and histologic observations in cynomolgus monkeys. Clin Oral Implants Res. 2003 Aug;14(4):404-11. doi: 10.1034/j.1600-0501.2003.120910.x.

  PMID: 12869002 BACKGROUND

• Schou S, Holmstrup P, Jorgensen T, Stoltze K, Hjorting-Hansen E, Wenzel A. Autogenous bone graft and ePTFE membrane in the treatment of peri-implantitis. I. Clinical and radiographic observations in cynomolgus monkeys. Clin Oral Implants Res. 2003 Aug;14(4):391-403. doi: 10.1034/j.1600-0501.2003.120909.x.

  PMID: 12869001 BACKGROUND

• Javed F, Al-Askar M, Al-Rasheed A, Al-Hezaimi K. Significance of the platelet-derived growth factor in periodontal tissue regeneration. Arch Oral Biol. 2011 Dec;56(12):1476-84. doi: 10.1016/j.archoralbio.2011.06.020. Epub 2011 Jul 20.

  PMID: 21774915 BACKGROUND

• Jung RE, Glauser R, Scharer P, Hammerle CH, Sailer HF, Weber FE. Effect of rhBMP-2 on guided bone regeneration in humans. Clin Oral Implants Res. 2003 Oct;14(5):556-68. doi: 10.1034/j.1600-0501.2003.00921.x.

  PMID: 12969359 BACKGROUND

• Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.

  PMID: 22754901 BACKGROUND

• Faggion CM Jr, Listl S, Tu YK. Assessment of endpoints in studies on peri-implantitis treatment--a systematic review. J Dent. 2010 Jun;38(6):443-50. doi: 10.1016/j.jdent.2010.03.003. Epub 2010 Mar 11.

  PMID: 20226832 BACKGROUND

• Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.

  PMID: 21488935 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 Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.

  PMID: 29926955 BACKGROUND

• Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. doi: 10.1111/j.1600-0501.2006.01320.x.

  PMID: 17348880 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

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: December 5, 2018
• First Posted: December 11, 2018
• Study Start: December 4, 2018
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: January 5, 2022

Record last verified: 2021-12

Locations

US (1)