Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04829968 |
| Other study ID # |
PERIHIV2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
November 30, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Università Vita-Salute San Raffaele |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
2.1 Type and sample of the study This retrospective monocentric observational study assessed
the prevalence of peri-implant disease in HIV-positive patients treated at the department of
dentistry of our hos-pital. At the same hospital, the HIV-positive patients were undergoing
antiretroviral treat-ment. This study included 58 adult patients with at least one dental
implant and a total of 222 implants followed for at least one year. Demographic, clinical,
and laboratory infor-mation of the patients was collected. All procedures were approved by
the appropriate lo-cal ethics committee. Appropriate informed consent forms were provided to
all patients and were signed if the patients agreed to participate in the study.
This study has been reported according to the STrengthening the Reporting of OBserva-tional
studies in Epidemiology (STROBE) guidelines and checklist.
2.2 Study design All included patients were divided into two groups, according to the type of
prosthesis in-serted after implant placement (all-on-4 prosthesis versus single
crowns\bridges), to as-sess the differences between the two types of prostheses in the
inflammatory state, and therefore, in the presence of mucositis and peri-implantitis as well
as in the variables ana-lysed.
As shown in Table 1, the data related to the immunological and systemic profile of the
pa-tients (HIVRNA load, CD4+ level, CD8+ level, haemoglobin level, and platelet count) were
collected through the database of the hospital.
2.3 Case definition for peri-implant condition: The clinical and radiological data for the
diagnosis of peri-implant disease were collected according to the criteria laid in the
Periodontology World Workshop in 2017 by Renvert et al. (2018).
2.3.1 Clinical Examination Data
- 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.
2.3.2 Radiological Examination Data Intraoral periapical radiographs are considered
gold standard for radiological evaluation and were used in this study. The
radiographic data were collected from the records of the patient. The position of
the marginal bone was measured manually on an ultraspeed radio-graphic film (Ultra
speed, Kodak, USA) using a dental calliper (0 to 10 mm). The distance to the
marginal bone was measured from the mesial and distal aspects of the implants. The
implant platform was used as a reference for the measurements. Two vertical lines
were drawn parallel to a vertical line passing through the centre of the implant.
The largest value was considered for statistical analysis. All assessments were
performed by a single inves-tigator (LC).
- Peri-implantitis:
1. Progressive bone loss in relation to the radiographic bone level assessment
performed after one year following the delivery of the implant-supported
prosthesis.
Inclusion criteria All patients (>18 years old), who were undergoing antiretroviral therapy
at the same hos-pital, who had undergone prosthetic rehabilitation using one or more dental
implants, with at least one year of follow-up after loading, and who had returned for a
maintenance ap-pointment were considered for inclusion.
Exclusion criteria Patients who discontinued antiretroviral therapy, patients not undergoing
therapy, patients whose previous radiographs and data on bleeding on probing and PPD at
gingival level were unknown, patients with decompensated systemic diseases (for example,
decompen-sated diabetes mellitus), patients treated with drugs that affect the bone turnover
(for ex-ample, bisphosphonates), and patients under 18 years of age were not included in this
study.
2.4 Statistical analysis A descriptive analysis was performed to assess all the obtained
data. Continuous quantita-tive variables were described as medians and interquartile ranges,
and categorical qualita-tive variables as frequencies and percentages (%). The continuous
variables are graphical-ly represented using boxplots [the box shows the first (Q1), second
(median), and third quartiles (Q3), and as whiskers, the values correspond to 1.5 times Q3] and categorical variables using bar graphs. The quantitative variables
were compared using the non-parametric Mann-Whitney test and qualitative variables using the
chi-square test or Fisher's exact test. Stepwise multivariate logistic regression analysis
was used to calculate the adjusted risks (odds), respective 95% confidence intervals, and
probability (p-value) of developing peri-implantitis and mucositis. All analyses were
performed using SAS for Windows Software (Version 9.4, SAS Institute). All statistical tests
were ap-plied to 2 sails, and values were considered significant if the calculated
probability was <0.05. The following two types of analyses were performed: the first analysed
the varia-bles individually in the entire study population and the other in the population
divided into 2 groups according to the type of implant-prosthetic rehabilitation performed.
