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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05772078
Other study ID # 20230208
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date October 30, 2023

Study information

Verified date October 2023
Source Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date October 30, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Assess compliance rate and demographics
Records to evaluate attendance rate

Locations

Country Name City State
Spain Centro de Implantologia Cirugia Oral y Maxilofacial Badajoz

Sponsors (1)

Lead Sponsor Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Cumulative Interceptive Rate 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
Primary Compliance rate How many patients are complete compliers 1 to 6 years of follow-up
Secondary Demographics Evaluate the patient-related features affecting compliance 1 to 6 years of follow-up
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