- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04259840
Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty
January 7, 2021 updated by: Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty. A Retrospective Study
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.
Study Overview
Detailed Description
The records of patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic will be examined and analyzed.
Patients who meet the inclusion/exclusion criteria will be contacted and invited to participate in the study to measure the following in a single visit: bleeding on probing, edema, redness of the peri-implant mucosa, and peri-implant probing pocket depth.
Additionally, patients will be asked to complete a survey during their study visit regarding their implant(s) and previous peri-implantitis.
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan School of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Soft tissue implant measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss
Time Frame: Up to 30 years after the implant was treated for peri-implantitis
|
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
Time Frame: Up to 30 years after the implant was treated for peri-implantitis
|
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
Time Frame: Up to 30 years after the implant was treated for peri-implantitis
|
The implant has probing depths less than or equal to 5 millimeters.
|
Up to 30 years after the implant was treated for peri-implantitis
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Survival rate of the peri-implantitis treated dental implants
Time Frame: Up to 30 years after the implant was treated for peri-implantitis
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Machtei EE. Treatment Alternatives to Negotiate Peri-Implantitis. Adv Med. 2014;2014:487903. doi: 10.1155/2014/487903. Epub 2014 Jun 15.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2019
Primary Completion (Actual)
March 10, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 7, 2020
Study Record Updates
Last Update Posted (Actual)
January 11, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00169996
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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