- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772078
Compliance and Cumulative Interceptive Rate After Therapy of Peri-implantitis
Compliance Rate After Therapy of Peri-implantitis: Retrospective Study
Peri-implantitis is a plaque-mediated inflammatory condition featured by progressive bone loss. This entity jeopardizes the longevity of dental implants, thus impacting negatively on the quality of life of patients. Moreover, peri-implantitis is suggested to lead to an increased systemic status of inflammation. This may rise the susceptibility to experience life-threating conditions. Therefore, peri-implant infections must be promptly diagnosed and eliminated.
Aiming at resolving the inflammation, several options are advised to remove the infection. Accordingly, implant removal or therapeutic manoeuvres to stablish a healthy ecosystem in the peri-implant environment have been suggested. While the former proved being more predictable, the later demonstrated being more conservative. Indeed, implant removal is commonly associated with regenerative procedures of the alveolar bone deformity that often demand time and is more costly. Anyways, disease severity, implant expendability for biomechanical reasons or esthetic demand seem to be few of the leading aspects in the decision-making process on maintaining or extracting implant showing peri-implant lesions.
Supportive maintenance care (SPT) was shown to be key in preventing disease recurrence. Nonetheless, the compliance of these patients is often erratic. In fact, it is yet unknown the rate of compliance after therapy. Therefore, the goal of this study is to assess the rate and confounders for compliance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Badajoz, Spain, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients that underwent treatment of peri-implantitis
- >12 months of follow-up after therapy
- Patients managed in our center
Exclusion Criteria:
- Patients that were managed in other centers
- Patients that have incomplete records
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Compliers
Attending to SPT every 4-6 months
|
Records to evaluate attendance rate
|
Erratic compliers
Attending to SPT once a year or sporadically
|
Records to evaluate attendance rate
|
Non compliers
Non-attenders to SPT
|
Records to evaluate attendance rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance rate
Time Frame: 1 to 6 years of follow-up
|
How many patients are complete compliers
|
1 to 6 years of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics
Time Frame: 1 to 6 years of follow-up
|
Evaluate the patient-related features affecting compliance
|
1 to 6 years of follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Interceptive Rate
Time Frame: 1 to 6 years of follow-upo
|
Interventions needed after active therapy to manage peri-implantitis during supportive peri-implant care for erratic and regular compliers
|
1 to 6 years of follow-upo
|
Collaborators and Investigators
Investigators
- Study Chair: Mamen Tomé, DH, Assistant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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