Peri-ImplantitisPERIHIV2NCT04829968
Peri-implantitis in HIV-positive Patients
An observational study of Peri-Implantitis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-Implantitis
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 30 Nov 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: 58 HIV-positive patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valutazione Del Profilo di Emergenza e Del Sovracontorno in Corone Protesiche Complete su Denti Naturali Preparati Senza Linea di Finitura (BOPT): Studio Retrospettivo
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.
Read more
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.
Read the detailed 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:
- 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.
- Presence of profuse (line or drop) bleeding and/or suppuration on probing.
- An increase in probing pocket depths (PPDs) compared to baseline.
- Peri-implantitis: It was diagnosed on the basis of the following criteria:
- Visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration.
- 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:
- 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 <Q1 and 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.
- Conditions
- Peri-Implantitis
- Being tested
- gingival conditions control
- Keywords
- peri-implantitis, mucositis, HIV-positive patients, All-on-4
- Medical subject headings
- Peri-Implantitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival conditions controlOther
Peri-implant mucositis: It was diagnosed on the basis of the following criteria:
- 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.
- Presence of profuse (line or drop) bleeding and/or suppuration on probing.
- An increase in probing pocket depths (PPDs) compared to baseline. • Peri-implantitis: It was diagnosed on the basis of the following criteria:
- Visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration.
- Increasing PPDs as compared to measurements recorded at the time of placement of supra-structures.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Jan 2015
- Primary completion1 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Casula, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829968
- Sponsor's protocol ID
- PERIHIV2
- Acronym
- PERIHIV2
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34288560
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Del Profilo di Emergenza e Del Sovracontorno in Corone Protesiche Complete su Denti Naturali Preparati Senza Linea di Finitura (BOPT): Studio Retrospettivo
- ClinicalTrials.gov ID
- NCT04829968
- Acronym / sponsor ID
- PERIHIV2 / PERIHIV2
- Conditions
- Peri-Implantitis
- Keywords
- peri-implantitis, mucositis, HIV-positive patients, All-on-4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- Presence of profuse (line or drop) bleeding and/or suppuration on probing.
- An increase in probing pocket depths (PPDs) compared to baseline.
- Peri-implantitis: It was diagnosed on the basis of the following criteria:
- Visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration.
- 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:
- 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 <Q1 and 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 58 HIV-positive patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival conditions controlPeri-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. | Other | – |
Primary outcome
Peri-implantitis prevalence
Time frame: 3 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Derived from this study: PubMed 34288560Casula 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implantitis prevalence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.