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Clinical Trials/NCT03772652
NCT03772652
Terminated
Not Applicable

Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

University of Michigan1 site in 1 country38 target enrollmentDecember 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
University of Michigan
Enrollment
38
Locations
1
Primary Endpoint
Therapeutic resolution of the peri-implantitis as measured by probing depths
Status
Terminated
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2018
End Date
February 13, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hom-Lay Wang, DDS, MSD, Ph D

Collegiate Professor of Periodontics and Professor of Dentistry

University of Michigan

Eligibility Criteria

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 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.

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)

Outcomes

Primary Outcomes

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.

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).

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.

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.

Study Sites (1)

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