NCT05772078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 30, 2024

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

March 6, 2023

Last Update Submit

April 27, 2024

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

  • Compliance rate

    How many patients are complete compliers

    1 to 6 years of follow-up

Secondary Outcomes (1)

  • Demographics

    1 to 6 years of follow-up

Other Outcomes (1)

  • Cumulative Interceptive Rate

    1 to 6 years of follow-upo

Study Arms (3)

Compliers

Attending to SPT every 4-6 months

Other: Assess compliance rate and demographics

Erratic compliers

Attending to SPT once a year or sporadically

Other: Assess compliance rate and demographics

Non compliers

Non-attenders to SPT

Other: Assess compliance rate and demographics

Interventions

Assess compliance rate and demographicsOTHER

Records to evaluate attendance rate

CompliersErratic compliersNon compliers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients that underwent treatment of peri-implantitis
  • \>12 months of follow-up after therapy
  • Patients managed in our center

You may not qualify if:

  • Patients that were managed in other centers
  • Patients that have incomplete records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, 06011, Spain

Location

Related Publications (1)

  • Monje A, Galindo-Fernandez P, Nart J. Supportive therapy following peri-implantitis treatment: A retrospective study on compliance. Clin Oral Implants Res. 2024 Jun;35(6):621-629. doi: 10.1111/clr.14257. Epub 2024 Mar 26.

    PMID: 38530213DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Demography

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Mamen Tomé, DH

    Assistant

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Periodontics

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2023

Study Completion

October 30, 2023

Last Updated

April 30, 2024

Record last verified: 2023-10

Locations

ES(1)