Peri-implantitis in HIV-positive Patients With Different Dental Prosthesis
PERIHIV
1 other identifier
observational
85
1 country
1
Brief Summary
Dental implants are widely used in human immunodeficiency virus (HIV)-positive patients, but the interaction between immune status and success of implant therapy, especially in such patients, is not clear. This study aimed to assess the prevalence of peri-implantitis in HIV-positive patients and to evaluate the presence of a possible correlation between the immunological profile and serological values of the same HIV-positive patients, of peri-implantitis, and of possible differences between all-on-4 and single crown/bridge prostheses in terms of peri-implant disease and the variables analyzed. This cross sectional study included 85 adult HIV-positive patients (394 implants) with at least one dental implant loaded for more than a year who were followed for at least one year. The patients were divided into patients with all-on-4 prosthesis and those with single crowns/bridges to assess the differences between the two types of prostheses in the inflammatory state, in the presence of mucositis and peri-implantitis, and in the variables analyzed. The following clinical parameters were assessed: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing pocket depth (PPD) in six sites per implant and tooth (deepest value for each implant and tooth was registered), PI and BoP measured as presence/absence at six sites per implant and tooth, presence of suppuration, mobility (measured by manual palpation) and number of lost teeth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedJuly 30, 2021
July 1, 2021
3 months
July 8, 2021
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prevalence of peri-implantitis
peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with a progressive loss of supporting bone
01/01/2015 - 01/01/2020
Interventions
patient were called and visited in the dentistry department and gingival sulcus were gentle probed to assess gingiva and peri-implant tissues status
Eligibility Criteria
patients with detected HIV infection and under retroviral therapy (HAART) that had positioned at least 1 dental implant with at least one year follow-up
You may qualify if:
- patients (\>18 years old) who had undergone prosthetic rehabilitation using one or more dental implants, with at least 1 year of follow-up after loading, and
- patients who had returned for a maintenance appointment at the Ville Turro Dental Clinic of Vita-Salute San Raffaele University in Milan
- patients under antiretroviral therapy (ART) at the same hospital.
You may not qualify if:
- Patients who discontinued antiretroviral therapy
- patients not undergoing therapy
- patients with uncontrolled systemic diseases (diabetes \[HbA1c\>7\])
- patients under treatment with any medications that may have an effect on bone turnover and mucosal healing (steroids, bisphosphonate therapy )
- Pregnancy or breastfeeding women
- patients who discontinued the oral maintenance (more than 1 appointment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ville Turro, San Raffaele Hospital
Milan, 20128, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Msc
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 30, 2021
Study Start
March 20, 2020
Primary Completion
June 20, 2020
Study Completion
July 20, 2020
Last Updated
July 30, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share