NCT04983212

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

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 8, 2021

Last Update Submit

July 19, 2021

Conditions

Keywords

peri-implantitisHIV-positiveMucositis

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Peri-ImplantitisHIV SeropositivityMucositis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

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

Locations