Peri-ImplantitisNCT05358782
The Influence of Implant Position on the Occurrence of Biological Complications
An observational study of Peri-Implantitis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The primary objective of this study will be to study the correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis, as evaluated after at least 6 months from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Dental implant positioning
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 6 Apr 2022to 6 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2021 (last follow-up included: 6 month visit on December 2021) in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Who may be able to join
- subjects aged more than 18 years old, treated with implants with moderately rough surface.
- subjects treated with dental implants at Istituto Ortopedico Galeazzi during the period between January 1st, 2005, and June 30th, 2021
- subjects without any systemic disease that could be an impact on bone metabolism (e.g. diabetes mellitus, osteoporosis, neoplasms)
- single and partial rehabilitations (without cantilever extension): single tooth restorations (one implant between two teeth or one single implant supporting single-tooth prosthesis with one adjacent tooth); multiple tooth restorations (one tooth per implant or bridges, splinted or not).
- complete information about patient status (systemic diseases, smoking status, medications, age, gender)
- complete description of the surgical and prosthetic protocol that was adopted.
- at least one periapical radiograph of good quality taken at the end of the intervention and a sufficient number of follow-up visits (at least one per year); the quality of the images will be assessed by the Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment ((UK) 2018), accepting Grade 1 and Grade 2 images.
- having clinical and / or radiographic records to assess periodontal status at the time of intervention.
Who cannot join
- Incomplete data (e.g. absence of periapical radiographs).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan
Stefano Corbella, 02 50319950, stefano.corbella@unimi.it
About this study
Official title: The Influence of Implant Position on the Occurrence of Biological Complications: a Retrospective, Observational Study on Periapical Radiographs
The primary objective of this study will be to study the correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis, as evaluated after at least 6 months from the placement of the prosthesis. The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2021 (last follow-up included: 6 month visit on December 2021) in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Will be included 45 implants with peri-implantitis and 135 healthy implants regardless of the corresponding number of patients . Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be measured through regression analysis, being the independent variable the occurrence of peri-implantitis. Multilevel analysis will be performed.
Read more
For all the analysis, the level of significance was set at p<0.05.
For sample size calculation the investigators have considered alpha = .05, power = 80% and a proportion between controls and cases of 3:1. The investigators hypothesized a detection of an effect of malposition with a proportion of 0.25 of exposes in control group and 0.5 in test group. the investigators decided to include 45 implants with peri-implantitis and 135 healthy implants, after augmenting the numbers hypothesizing a maximum of 10% dropouts. The proportion of exposed are estimated on the basis of the study published by Yi et al. in 2020 .
The calculation was performed using the method proposed by Schoenfeld.
Read the detailed description
The primary outcome was the occurrence of peri-implantitis described as:
- presence of signs of inflammation (bleeding and / or suppuration after probing);
- radiographic bone loss in addition to crestal bone resorption caused by initial remodeling or, in the absence of radiography at one year, bone level positioned ≥ 3 mm apically to the most coronal portion of the intraosseous portion of the implant body;
- presence of increased probing depth as compared to previous measurements, if available.
Implant malposition will be defined on the basis of the following parameters:
- criteria proposed by Buser and coworkers in 2004: at least 1.5 - 2 mm between implant neck and adjacent tooth (mesio-distal); ii) at least 1 mm of apico-coronal distance between implant neck and the Cemento-enamel Junction (CEJ) of adjacent teeth (no more than 2.5 mm); iii) at least 3 mm between the necks of two adjacent implants.
- inclination of the implant axis as compared the axis of adjacent teeth (both mesial and distal if present)
- characteristics of the prosthesis (emergency profile, presence of cantilevers, imprecise implant-abutment connection)
The following parameters will be collected from clinical records:
- implant-related factors: implant type, length, diameter, and type of implant-abutment connection, implant surface, vertical position of the implant (distance between implant neck and the bone level at the time of intervention (I-BC) (periapical radiograph)), distance between the implant neck margin and adjacent teeth (on periapical radiographs) (I-MT, I-DT [I-MI, I-DI]), distance between implant neck and the projection of CEJ of adjacent teeth (periapical radiographs) (I-MT-CEJ, I-DT-CEJ), the angle between the projection of the implant axis and the axis of adjacent teeth or implant.
- patient-related factors: age, gender, smoking status, systemic disease, medications, presence of periodontal disease at the time of intervention (severity), history of periodontal disease, bruxism;
- site-related factors: implant position / site, bone quantity / quality following the Lekholm and Zarb classification;
- prosthesis-related factors (to be evaluated using the radiographs taken after placement of the prosthesis): single crown, partial fixed denture, ceramic- or resin-made, time of loading, fixation methods (screwed or cemented), platform switching, crown height (I-CH), extension of prosthetic cantilever (only for single-tooth restorations) (mesial and / or distal) (C-M, C-D), angle of emergency profile (mesial and distal) (C-M-EP, C-D-EP), presence of misfit of the prosthesis.
Clinical data will be completely anonymized through the association of each subject to one identification code, and the elimination of the document containing the link between them.
- Conditions
- Peri-Implantitis
- Being tested
- Dental implant positioning
- Keywords
- peri-implant loss, dental radiography, implant malposition
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant positioningDevice
observational study of the effect of implant malposition
| Study group | Role | What they receive |
|---|---|---|
| Implant with peri-implantitis | Implant with progressive marginal bone loss Receives: Device: Dental implant positioning | |
| Healthy implant | Implant without any sign of marginal bone loss Receives: Device: Dental implant positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of peri-implantitis
Correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis
Measured: 198 months
Secondary outcomes (4)
occurence of peri-implantitis independently from smoking/periodontitis
assess how implant position is related to the occurrence of peri-implantitis, independently from the exposure to smoking or to periodontitis
Measured: 198 months
operator's experience
the influence of operator's experience on the odds of development of peri-implantitis
Measured: 198 months
implant-tooth and implant-implant distance
- the occurrence of peri-implantitis as related to absolute values of implant-tooth and implant-implant distance
Measured: 198 months
characteristics of the prosthesis
- the occurrence of peri-implantitis as related to characteristics of the prosthesis (emergency profile, cantilevers, imprecise implant-abutment connection)
Measured: 198 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start6 Apr 2022
- Primary completion6 Oct 2022 (estimated)
- Study completion6 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358782
- Sponsor's protocol ID
- IMP-MAL
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Quality assessment of radiographs. 2018. London: FGDP(UK); [accessed]. https://www.fgdp.org.uk/SiD/a2-quality-assessment-radiographs.
Arunyanak SP, Sophon N, Tangsathian T, Supanimitkul K, Suwanwichit T, Kungsadalpipob K. The effect of factors related to periodontal status toward peri-implantitis. Clin Oral Implants Res. 2019 Aug;30(8):791-799. doi: 10.1111/clr.13461. Epub 2019 Jun 12.
PubMed 31107993Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
PubMed 15635945Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20.
PubMed 26584716Ferreira SD, Martins CC, Amaral SA, Vieira TR, Albuquerque BN, Cota LOM, Esteves Lima RP, Costa FO. Periodontitis as a risk factor for peri-implantitis: Systematic review and meta-analysis of observational studies. J Dent. 2018 Dec;79:1-10. doi: 10.1016/j.jdent.2018.09.010. Epub 2018 Nov 2.
PubMed 30391683Francetti L, Cavalli N, Taschieri S, Corbella S. Ten years follow-up retrospective study on implant survival rates and prevalence of peri-implantitis in implant-supported full-arch rehabilitations. Clin Oral Implants Res. 2019 Mar;30(3):252-260. doi: 10.1111/clr.13411. Epub 2019 Feb 18.
PubMed 30702771Lekholm U, Zarb GA. 1985. Patient selection and preparation. In: Branemark PI, Zarb GA, Albrektsson T, editors. Tissue-integrated prostheses: Osseointegration in clinical dentistry. Chicago: Quintessence. p. 199-209.
Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23.
PubMed 26701350Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
PubMed 6354290Yi Y, Koo KT, Schwarz F, Ben Amara H, Heo SJ. Association of prosthetic features and peri-implantitis: A cross-sectional study. J Clin Periodontol. 2020 Mar;47(3):392-403. doi: 10.1111/jcpe.13251. Epub 2020 Jan 21.
PubMed 31912511
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Implant Position on the Occurrence of Biological Complications: a Retrospective, Observational Study on Periapical Radiographs
- ClinicalTrials.gov ID
- NCT05358782
- Acronym / sponsor ID
- IMP-MAL
- Conditions
- Peri-Implantitis
- Keywords
- peri-implant loss, dental radiography, implant malposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 6 Oct 2022 (estimated)
- Study completion
- 6 Feb 2023 (estimated)
- First posted
- 3 May 2022 (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.
The primary objective of this study will be to study the correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis, as evaluated after at least 6 months from the placement of the prosthesis. The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2021 (last follow-up included: 6 month visit on December 2021) in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Will be included 45 implants with peri-implantitis and 135 healthy implants regardless of the corresponding number of patients . Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be measured through regression analysis, being the independent variable the occurrence of peri-implantitis. Multilevel analysis will be performed.
For all the analysis, the level of significance was set at p<0.05.
For sample size calculation the investigators have considered alpha = .05, power = 80% and a proportion between controls and cases of 3:1. The investigators hypothesized a detection of an effect of malposition with a proportion of 0.25 of exposes in control group and 0.5 in test group. the investigators decided to include 45 implants with peri-implantitis and 135 healthy implants, after augmenting the numbers hypothesizing a maximum of 10% dropouts. The proportion of exposed are estimated on the basis of the study published by Yi et al. in 2020 .
The calculation was performed using the method proposed by Schoenfeld.
Detailed description
The primary outcome was the occurrence of peri-implantitis described as:
- presence of signs of inflammation (bleeding and / or suppuration after probing);
- radiographic bone loss in addition to crestal bone resorption caused by initial remodeling or, in the absence of radiography at one year, bone level positioned ≥ 3 mm apically to the most coronal portion of the intraosseous portion of the implant body;
- presence of increased probing depth as compared to previous measurements, if available.
Implant malposition will be defined on the basis of the following parameters:
- criteria proposed by Buser and coworkers in 2004: at least 1.5 - 2 mm between implant neck and adjacent tooth (mesio-distal); ii) at least 1 mm of apico-coronal distance between implant neck and the Cemento-enamel Junction (CEJ) of adjacent teeth (no more than 2.5 mm); iii) at least 3 mm between the necks of two adjacent implants.
- inclination of the implant axis as compared the axis of adjacent teeth (both mesial and distal if present)
- characteristics of the prosthesis (emergency profile, presence of cantilevers, imprecise implant-abutment connection)
The following parameters will be collected from clinical records:
- implant-related factors: implant type, length, diameter, and type of implant-abutment connection, implant surface, vertical position of the implant (distance between implant neck and the bone level at the time of intervention (I-BC) (periapical radiograph)), distance between the implant neck margin and adjacent teeth (on periapical radiographs) (I-MT, I-DT [I-MI, I-DI]), distance between implant neck and the projection of CEJ of adjacent teeth (periapical radiographs) (I-MT-CEJ, I-DT-CEJ), the angle between the projection of the implant axis and the axis of adjacent teeth or implant.
- patient-related factors: age, gender, smoking status, systemic disease, medications, presence of periodontal disease at the time of intervention (severity), history of periodontal disease, bruxism;
- site-related factors: implant position / site, bone quantity / quality following the Lekholm and Zarb classification;
- prosthesis-related factors (to be evaluated using the radiographs taken after placement of the prosthesis): single crown, partial fixed denture, ceramic- or resin-made, time of loading, fixation methods (screwed or cemented), platform switching, crown height (I-CH), extension of prosthetic cantilever (only for single-tooth restorations) (mesial and / or distal) (C-M, C-D), angle of emergency profile (mesial and distal) (C-M-EP, C-D-EP), presence of misfit of the prosthesis.
Clinical data will be completely anonymized through the association of each subject to one identification code, and the elimination of the document containing the link between them.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant with peri-implantitis | – | Device: Dental implant positioningImplant with progressive marginal bone loss |
| Healthy implant | – | Device: Dental implant positioningImplant without any sign of marginal bone loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2021 (last follow-up included: 6 month visit on December 2021) in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Key inclusion criteria (8 listed)
- subjects aged more than 18 years old, treated with implants with moderately rough surface.
- subjects treated with dental implants at Istituto Ortopedico Galeazzi during the period between January 1st, 2005, and June 30th, 2021
- subjects without any systemic disease that could be an impact on bone metabolism (e.g. diabetes mellitus, osteoporosis, neoplasms)
- single and partial rehabilitations (without cantilever extension): single tooth restorations (one implant between two teeth or one single implant supporting single-tooth prosthesis with one adjacent tooth); multiple tooth restorations (one tooth per implant or bridges, splinted or not).
- complete information about patient status (systemic diseases, smoking status, medications, age, gender)
Key exclusion criteria (1 listed)
- Incomplete data (e.g. absence of periapical radiographs).
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 |
|---|---|---|
| Dental implant positioningobservational study of the effect of implant malposition | Device | Healthy implant, Implant with peri-implantitis |
Primary outcome
occurence of peri-implantitis
Time frame: 198 months
Correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis
4 secondary outcomes
occurence of peri-implantitis independently from smoking/periodontitis
Time frame: 198 months
operator's experience
Time frame: 198 months
implant-tooth and implant-implant distance
Time frame: 198 months
characteristics of the prosthesis
Time frame: 198 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- BackgroundQuality assessment of radiographs. 2018. London: FGDP(UK); [accessed]. https://www.fgdp.org.uk/SiD/a2-quality-assessment-radiographs.
- Background: PubMed 31107993Arunyanak SP, Sophon N, Tangsathian T, Supanimitkul K, Suwanwichit T, Kungsadalpipob K. The effect of factors related to periodontal status toward peri-implantitis. Clin Oral Implants Res. 2019 Aug;30(8):791-799. doi: 10.1111/clr.13461. Epub 2019 Jun 12.
- Background: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Background: PubMed 15635945Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
- Background: PubMed 26584716Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20.
- Background: PubMed 30391683Ferreira SD, Martins CC, Amaral SA, Vieira TR, Albuquerque BN, Cota LOM, Esteves Lima RP, Costa FO. Periodontitis as a risk factor for peri-implantitis: Systematic review and meta-analysis of observational studies. J Dent. 2018 Dec;79:1-10. doi: 10.1016/j.jdent.2018.09.010. Epub 2018 Nov 2.
- Background: PubMed 30702771Francetti L, Cavalli N, Taschieri S, Corbella S. Ten years follow-up retrospective study on implant survival rates and prevalence of peri-implantitis in implant-supported full-arch rehabilitations. Clin Oral Implants Res. 2019 Mar;30(3):252-260. doi: 10.1111/clr.13411. Epub 2019 Feb 18.
- BackgroundLekholm U, Zarb GA. 1985. Patient selection and preparation. In: Branemark PI, Zarb GA, Albrektsson T, editors. Tissue-integrated prostheses: Osseointegration in clinical dentistry. Chicago: Quintessence. p. 199-209.
- Background: PubMed 26701350Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23.
- Background: PubMed 6354290Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
- Background: PubMed 31912511Yi Y, Koo KT, Schwarz F, Ben Amara H, Heo SJ. Association of prosthetic features and peri-implantitis: A cross-sectional study. J Clin Periodontol. 2020 Mar;47(3):392-403. doi: 10.1111/jcpe.13251. Epub 2020 Jan 21.
- Individual participant dataSharing planned: Undecided
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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.
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 I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 8 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Corbella, PhD, Researcher (3386842640, stefano.corbella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of peri-implantitis (time frame: 198 months). 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 NCT05358782, which also lists 11 linked publications.
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 9 May 2022.