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Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

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ClinicalTrials.gov Identifier: NCT03772652
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan

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.

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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long-term Surgical Therapeutic Outcomes of Peri-Implantitis
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Group/Cohort Intervention/treatment
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
Soft tissue implant measurements




Primary Outcome Measures :
  1. Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss [ Time Frame: At least five 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: At least five 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: At least five 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: At least five 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).



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

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): NCT03772652


Contacts
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Contact: Hom-Lay Wang, DDS MSD PhD 734-764-9148 homlay@umich.edu
Contact: Alice Ou, RDH MS 734-763-3346 aliceou@umich.edu

Locations
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United States, Michigan
University of Michigan School of Dentistry Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Hom-Lay Wang, DDS MSD PhD    734-764-9148    homlay@umich.edu   
Contact: Alice Ou, RDH MS    734-763-3346    aliceou@umich.edu   
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:

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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: NCT03772652     History of Changes
Other Study ID Numbers: HUM00148346
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
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