Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

NCT ID: NCT03772652

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-02-13

Brief Summary

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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.

Detailed Description

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Qualifying patients will be asked to participate in clinical measurements to compare the long-term success of their treatments.

The aims of the current study are to 1) assess the long-term outcome of the surgical treatment of peri-implantitis and to 2) evaluate the success of the different treatment modalities of peri-implantitis.

Conditions

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Peri-Implantitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Observation

Intervention Type OTHER

Soft tissue implant measurements

Interventions

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Observation

Soft tissue implant measurements

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. The patient is at least 18 years of age,
2. 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),
3. had received treatment for peri-implantitis at least 5 years ago at the Graduate Clinic of Periodontics at University of Michigan, and
4. documentation from ≥ 5 years of clinical and radiological follow-up is available from U of M patients records.

Exclusion Criteria

1. Has received or is currently receiving radiotherapy,
2. are currently pregnant, unsure of their pregnancy status, or are lactating (as reported by the patient),
3. has health condition(s) or takes medication(s) that are known to affect soft tissue or bone (e.g., Phenytoin)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Hom-Lay Wang, DDS, MSD, Ph D

Collegiate Professor of Periodontics and Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hom-Lay Wang, DDS MSD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontics and Oral Medicine University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23537178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18724855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21323713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22533957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25495683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18476998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18437796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28906504 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26556414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17348882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20132246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11759861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24438600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12869002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12869001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21774915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12969359 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22754901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20226832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21488935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29926955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17348880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28548886 (View on PubMed)

Other Identifiers

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HUM00148346

Identifier Type: -

Identifier Source: org_study_id

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