NCT04829968

Brief Summary

Objectives: This study aimed to assess the prevalence of peri-implantitis in human im-munodeficiency virus (HIV) -positive patients and the presence of a possible correlation between the immunological profile and serological values, of peri-implantitis, and of pos-sible differences between all-on-4 and single crown/bridge prostheses. Subjects and methods: This retrospective study included 58 adult HIV-positive patients (222 implants) with either all-in-4 prostheses or single crowns/bridges on at least one dental implant loaded for more than a year who were followed for at least one year. Data pertaining to the probing pocket depth (PPD), bleeding on probing, and immunological and systemic profile were collected. Results: Patients with single crown/bridge implant rehabilitation showed higher preva-lence of peri-implantitis (34%) than patients with all-on-4 rehabilitation (0%) (p=0.012). Patients with all-on-4 rehabilitation were significantly older than those with single crowns/bridges (p=0.004). Patients with peri-implantitis had implants for a significantly longer duration than those without (p=0.001), implying that the probability of peri-implantitis increases as the age of implant increases. Conclusions: The prevalence of peri-implantitis was 26% in HIV-positive patients and 8% in dental implants. No correlation was found between patients' immunological and se-rological factors and peri-implantitis. The most important risk factor for peri-implantitis and mucositis was implant age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

Study Start

First participant enrolled

January 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

March 30, 2021

Last Update Submit

March 31, 2021

Conditions

Keywords

peri-implantitismucositisHIV-positive patientsAll-on-4

Outcome Measures

Primary Outcomes (1)

  • Peri-implantitis prevalence

    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.

    3 years

Interventions

Peri-implant mucositis: It was diagnosed on the basis of the following criteria: 1. Visual inspection demonstrating the following signs of inflammation in the peri-implant region: red as opposed to pink colour, swollen tissues as opposed to no swelling, and soft as opposed to firm tissue consistency. 2. Presence of profuse (line or drop) bleeding and/or suppuration on probing. 3. An increase in probing pocket depths (PPDs) compared to baseline. • Peri-implantitis: It was diagnosed on the basis of the following criteria: 1\. Visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration. 2\. Increasing PPDs as compared to measurements recorded at the time of placement of supra-structures.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

58 HIV-positive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luca Casula

Monza, Monza E Della Brianza, 20900, Italy

Location

Related Publications (1)

  • Casula L, Poli A, Clemente T, Artuso G, Cappare P, Gherlone EF. Prevalence of peri-implantitis in a sample of HIV-positive patients. Clin Exp Dent Res. 2021 Dec;7(6):1002-1013. doi: 10.1002/cre2.469. Epub 2021 Jul 20.

MeSH Terms

Conditions

Peri-ImplantitisMucositis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc resident in Oral Surgery

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 2, 2021

Study Start

January 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 30, 2019

Last Updated

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations