Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04983212 |
| Other study ID # |
10/INT/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2020 |
| Est. completion date |
July 20, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
Università Vita-Salute San Raffaele |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
2.1 Study design This cross-sectional mono-centric observational study assessed the
prevalence of peri-implant disease in HIV-positive patients and was performed in accordance
with the Helsinki Declaration of Human Studies. All procedures were approved by the Ethics
Committee of Vita-Salute San Raffaele University (on 15/7/2020 with number of protocol
"PERIHIV"-EC Reg. N. 10/INT/2020) in Milan, Italy. This study has been reported according to
the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines
and checklist.
2.2 Patient sample Each patient was informed about all pertinent aspects of the study by the
investigator (LC), and an appropriate informed consent was obtained prior to the start of the
study. The study included 85 adult patients between 46.56 and 55.6 years (median 51.32 years)
with at least one dental implant and a total of 394 dental implants with a mean follow-up of
3 years (range from 2 years to 5 years). Demographic, clinical, and laboratory information of
the patients was collected and implant were positioned in the same Hospital in which patients
are in treating with antiretroviral therapy for the HIV-infection (Ville Turro Dental Clinic
of Vita-Salute San Raffaele University in Milan).
2.3 Inclusion and exclusion criteria All 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 who had returned for a maintenance appointment at the Ville
Turro Dental Clinic of Vita-Salute San Raffaele University in Milan. All patients were
undergoing antiretroviral therapy (ART) at the same hospital. Patients who discontinued
antiretroviral therapy and patients not undergoing therapy, subjects with uncontrolled
systemic diseases (diabetes [HbA1c>7]) or under treatment with any medications that may have
an effect on bone turnover and mucosal healing (steroids, bisphosphonate therapy ) were
excluded. Pregnancy or breastfeeding women were also excluded. All patients were included in
a maintenance oral hygiene program (every 4 months) and who discontinued the oral maintenance
(more than 1 appointment) were excluded from the study.
2.4 surgery procedure All implants were placed by two skilled implant surgeons; most of the
implants (328) were 3,8 mm diameter (83.2%), 46 were 3,3 mm (11.7%) and 20 were 4,5 mm
(5.1%). Implants were placed at level or slightly below the bone crest (1 mm) and in all
cases the complete bone healing was reached (at least 3 months) before implant loading. Bone
healing was assessed after at least 3 months of undisturbed healing, with periapical
radiographs and if confirmed, final impression was taken. For implant-supported single crown
and bridge, after final impression, definitive cemented single crown or bridge were achieved.
Only in cases of not adequate prosthetic space, with not sufficient abutment retention for
cemented prostheses, screw-retained prosthetic rehabilitations were made. Regarding the full
arch rehabilitations, the all-on-four protocol described by Malò were followed in all cases.
In addition the bone was leveled before implant placement using a rongeur and with the aid of
the carbide burs in order to form a flat bone plane in which place the implant. This allows
the elimination of the bone spicules, fractured bone and damaged buccal bone and the creation
of a flatbed in which was easy to insert the implants and achieve the prosthetic
rehabilitation. Two implants were placed in the posterior sectors (tilted) and two in the
anterior sector (straight) after the bone leveling.
2.4 Clinical evaluation Data pertaining probing pocket depth (PPD), bleeding on probing (BoP)
and plaque index (PI) around the implants and teeth of HIV-positive patients included in the
study were collected by probing implant and dental sulcus with a calibrated dental probe
(0,25 N)(Hawe Click-Probe®, KerrHawe SA, Switzerland) by one skilled operator (L.C.). 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. Demographic data and implant site characteristics were
checked in a specific case report form. For each HIV-positive patients, the following
information was reported: age, gender, smoking habit (number of cigarettes), number of dental
implants, health condition (i.e. diabetes presence), history of periodontitis and frequency
of maintenance (number of maintenance appointments in 1 year). Data relating to the
immunological and systemic profile of the patients (HIVRNA load, CD4+ level, CD8+ level,
hemoglobin level, platelet count) were collected through the database of the hospital.
For each implant, the following data were collected: diameter, location, time in function,
type of prosthesis (crown/bridge or all-on-4). The patients were divided into two groups,
according to the type of prosthesis inserted after implant placement, to assess 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 analyzed.
2.5 Radiologic examination and assessment of bone level When an implant showed BoP with or
without suppuration and/or PPD ≥ 3 mm after gentle probing, a periapical radiograph was taken
using the long-cone paralleling technique and using Rinn rings for the periapical images. The
position of the marginal bone was measured manually on ultra speed radiographic film (Ultra
speed, Kodak, USA) using a dental caliper (0 to 10 mm) and with the aid of 4.5X magnification
(EyeMag Pro F, Zeiss). The distance to the marginal bone was measured at the mesial and
distal aspects of the implants to the adjacent bone. The implant platform was used as
reference for the measurements. Two vertical lines were drawn parallel to the vertical line
crossing the centre of the implant. The largest value was recorded. Assessments were
performed by one investigator (PC).
2.6 Case definitions for peri-implant conditions The criteria described in 2017 in
Periodontology World Workshop by Renvert (2018) were used for peri-implant disease diagnosis:
Peri-implant mucositis was diagnoses in presence of visual inspection demonstrating the
presence of peri-implant signs of inflammation, presence of profuse bleeding and/or
suppuration on probing; an increase in probing depths compared to baseline and absence of
bone loss in relation to the baseline.
Peri-implantitis was diagnoses in presence of bleeding on probing and/or suppuration,
increasing probing pocket depths as compared to measurements obtained at placement of the
supra-structure and progressive bone loss in relation to the radiographic bone level
assessment at 1 year following the delivery of the implant-supported prosthetics
reconstruction. In the absence of initial radiographs and probing depths, radiographic
evidence of bone levels ≥ 3 mm apical of the most coronal portion of the intra-osseous part
of the implant and/or probing depths ≥6 mm in conjunction with profuse bleeding were used for
the diagnosis. Gentle probing.
2.7 Case definitions for history of periodontitis The criteria described in 2017 in
Periodontology World Workshop by Tonetti (2018) were used for history of periodontitis
diagnosis: Presence of periodontitis was detected as clinical attachment loss (CAL) with
reference to the cemento-enamel junction (CEJ) not ascribed to non-periodontal causes.
1. Interdental CAL detectable at ≥ 2 non-adjacent teeth
2. Buccal or oral CAL ≥3 mm with pocketing >3 mm detectable at ≥2 teeth CAL was assessed
with the periodontal probing or with direct visualization to detect the CEJ. Moreover to
confirm the CAL periapical radiographs and/or rx OPT were used.
