Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

December 13, 2021 updated by: Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

38

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

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

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

Description

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)

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

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: 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.
At least five years after the implant was treated for peri-implantitis
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.
At least five years after the implant was treated for peri-implantitis
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.
At least five years after the implant was treated for peri-implantitis
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).
At least five years after the implant was treated for peri-implantitis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

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

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 4, 2018

Primary Completion (Actual)

February 13, 2020

Study Completion (Actual)

February 13, 2020

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00148346

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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