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

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ClinicalTrials.gov Identifier: NCT04259840
Recruitment Status : Terminated (COVID-19 pandemic)
First Posted : February 7, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan

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.

Condition or disease Intervention/treatment
Peri-Implantitis Other: Observation

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.

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty. A Retrospective Study
Actual Study Start Date : December 5, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : July 1, 2020

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
Other: Observation
Soft tissue implant measurements




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Survival rate of the peri-implantitis treated dental implants [ Time Frame: Up to 30 years after the implant was treated for peri-implantitis ]
    Survival rate will be determined by the duration of implant survival (functioning, non-symptomatic implant after peri-implantitis treatment).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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 bone loss progression over physiological bone remodeling radiologically assessed or marginal bone loss ≥ 3 mm radiologically assessed in case of absence of baseline radiographs),
  3. had received treatment for peri-implantitis at least 1 year ago at the Graduate Clinic of Periodontics at University of Michigan, and
  4. documentation from ≥ 1 year 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)
  4. Received any kind of bone graft during the treatment of the peri-implantitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259840


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Hom-Lay Wang, DDS MSD PhD Department of Periodontics and Oral Medicine, University of Michigan
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hom-Lay Wang, DDS, MSD, Ph D, Collegiate Professor of Periodontics and Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT04259840    
Other Study ID Numbers: HUM00169996
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases