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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

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

      • Badajoz, Spain, 06011
        • Centro de Implantologia Cirugia Oral y Maxilofacial

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients that underwent therapy of peri-implantitis and were recommended to SPT

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

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

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

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

Investigators

  • Study Chair: Mamen Tomé, DH, Assistant

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)

July 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20230208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Publication

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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