Clinical trial NCT03772652: Long-term Surgical Therapeutic Outcomes of Peri-Implantitis
Official title: Long-term Surgical Therapeutic Outcomes of Peri-Implantitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peri-Implantitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were diagnosed with peri-implantitis and received treatment at least 5 years ago.

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.

Eligibility 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)

Primary outcomes:
measure: Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss
timeFrame: At least five years after the implant was treated for peri-implantitis
measure: Therapeutic resolution of the peri-implantitis as measured by erythema
timeFrame: At least five years after the implant was treated for peri-implantitis
measure: Therapeutic resolution of the peri-implantitis as measured by probing depths
timeFrame: At least five years after the implant was treated for peri-implantitis
measure: Survival rate of the peri-implantitis treated dental implants
timeFrame: At least five years after the implant was treated for peri-implantitis
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
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