Clinical trial NCT04259840: Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty
Official title: Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty. A Retrospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peri-Implantitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 41
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: Patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic from January 1, 1990 through July 1, 2018

Brief summary: The aims of the current study are 1) to assess the therapeutic resolution of the peri-implantitis after resective surgical treatment with or without implantoplasty procedure (no further radiographic bone loss, no erythema of the peri-implant mucosa, PD \<6mm), and 2) to evaluate the survival rate of the peri-implantitis treated dental implants.

Detailed description: The records of patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic will be examined and analyzed. Patients who meet the inclusion/exclusion criteria will be contacted and invited to participate in the study to measure the following in a single visit: bleeding on probing, edema, redness of the peri-implant mucosa, and peri-implant probing pocket depth. Additionally, patients will be asked to complete a survey during their study visit regarding their implant(s) and previous 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 bone loss progression over physiological bone remodeling radiologically assessed or marginal bone loss ≥ 3 mm radiologically assessed in case of absence of baseline radiographs),
3. had received treatment for peri-implantitis at least 1 year ago at the Graduate Clinic of Periodontics at University of Michigan, and
4. documentation from ≥ 1 year 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)
4. Received any kind of bone graft during the treatment of the peri-implantitis

Primary outcomes:
measure: Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss
timeFrame: Up to 30 years after the implant was treated for peri-implantitis
measure: Therapeutic resolution of the peri-implantitis as measured by erythema
timeFrame: Up to 30 years after the implant was treated for peri-implantitis
measure: Therapeutic resolution of the peri-implantitis as measured by probing depths
timeFrame: Up to 30 years after the implant was treated for peri-implantitis
measure: Survival rate of the peri-implantitis treated dental implants
timeFrame: Up to 30 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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