Compliance Rate After Surgical Therapy of Peri-implantitis

Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain (Other)
Overall Status
Recruiting
CT.gov ID
NCT05772078
Collaborator
(none)
140
1
2
69.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assess compliance rate and demographics

Study Design

Study Type:
Observational
Anticipated Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Compliance Rate After Surgical Therapy of Peri-implantitis: Retrospective Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Compliers

Attending to SPT every 4-6 months

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

Erratic compliers

Attending to SPT once a year or sporadically

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

Non compliers

Non-attenders to SPT

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

Outcome Measures

Primary Outcome Measures

  1. Compliance rate [1 to 6 years of follow-up]

    How many patients are complete compliers

Secondary Outcome Measures

  1. Demographics [1 to 6 years of follow-up]

    Evaluate the patient-related features affecting compliance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Implantologia Cirugia Oral y Maxilofacial Badajoz Spain 06011

Sponsors and Collaborators

  • Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Investigators

  • Study Chair: Mamen Tomé, DH, Assistant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alberto Monje, Director, Department of Periodontics, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
ClinicalTrials.gov Identifier:
NCT05772078
Other Study ID Numbers:
  • 20230208
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023