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Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT03772652
Collaborator
(none)
38
Enrollment
1
Location
14.3
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
38 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Long-term Surgical Therapeutic Outcomes of Peri-Implantitis
Actual Study Start Date :
Dec 4, 2018
Actual Primary Completion Date :
Feb 13, 2020
Actual Study Completion Date :
Feb 13, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan School of Dentistry Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hom-Lay Wang, DDS, MSD, Ph D, Collegiate Professor of Periodontics and Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier:
NCT03772652
Other Study ID Numbers:
  • HUM00148346
First Posted:
Dec 11, 2018
Last Update Posted:
Jan 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Peri-Implantitis

Study Results

No Results Posted as of Jan 5, 2022