Peri-ImplantitisNCT05592314
Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases
An observational study of Peri-Implantitis, run by Ramón Pons Calabuig at 1 site in Spain.
Trial summary
1. Objectives: To evaluate the influence of the shape and contour of implant-supported restorations on peri-implant soft and hard tissues by using an intraoral scanner. 2. Material and methods: 1. Number of patients to be treated: 120 2. Number of visits per patient: 1 3. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2021to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient presents at least one implant-supported restoration in the posterior region (molars and premolars), placed at the university between 2010 and 2017.
Who may be able to join
- Patients aged 18-80 years,
- Implant properly positioned (≥ 2 mm from the buccal plate and >1 mm from the lingual plate or in the ideal occlusal plane horizontally, 5 to 2 mm from the adjacent CEJ or from 2 mm below the residual ridge to crestal position (0 mm) apico-coronally and with an angulation of 70 to 90 degrees from the adjacent tooth long axis or from the ridge parallelism) (21),
- Implant loading for more than 3 years,
- Partial or total edentulism being restored with dental implants in the molar and premolar region with single or partial restorations.
- Patients who have not taken any antibiotic and regular NSAIDs in the last 2 months prior to the clinical examination,
Who cannot join
- Uncontrolled systemic diseases (i.e., diabetes mellitus)
- Pregnancy or lactation patients,
- Smokers of ≥10 cig/day.
- Zygomatic or pterygoid implants,
- Removable prostheses and cement-retained implant prostheses,
- Patients who have undergone non-surgical peri-implant treatment with prosthesis modifications, peri-implantitis surgical treatment or soft tissue augmentation procedures at the implant site.
- Intake of medications known to modify bone metabolism (i.e., hyperparathyroidism, osteoporosis, and vitamin D deficiency),
- Uncontrolled or active periodontal disease that required treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Ramón Pons, dds
About this study
Official title: Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases: a Cross Sectional Study
- Objectives: To evaluate the influence of the shape and contour of implant-supported restorations on peri-implant soft and hard tissues by using an intraoral scanner.
- Material and methods:
- Number of patients to be treated: 120
- Number of visits per patient: 1
- Brief description of the different techniques used in the study, authorized and validated in the literature (3-5 lines). A clinical and radiographic evaluation of the dental implants of those patients who are undergoing maintenance therapy treated by the Department of Periodontics of the International University of Catalonia prior to 2017 will be carried out. Additionally, a digital scan of the crown will be carried out using a intraoral scanner. Finally, patients will fill out a questionnaire about their routine dental care.
- Benefits and harms of participating in the study for the patient Participating in this study implies irradiating the patient through a periapical x-ray in order to assess the bone level of their implants and therefore be able to diagnose the presence or absence of peri-implant disease. Regarding the possible benefits, the patient will help the scientific community to determine the ideal contour and shape of the implant-supported restoration that will prevent the appearance of peri-implant diseases. Likewise, patients will undergo an exhaustive clinical and radiographic review that will allow their dental and periodontal status to be updated.
- Alternative treatment in case the patient does not wish to participate in the clinical study As this is an observational study, there is no alternative treatment. The patient will have absolute freedom to decline to participate in the study.
- Treatment to be carried out in the event that complications arise in the patient, once the clinical study has begun If after handling the prosthesis, it is detected that any of the screws that support the prostheses are loose or defective, the MORE department will be informed in order to replace said accessory. On the other hand, they would be informed in the same way in case of detecting any complication/alteration with the patient's implant-supported crowns.
- Material needed to carry out the study ( To carry out this study, you will need posterior radiographic positioners, radiographs, an intraoral scanner (3Shape Trios®), the implant analogs or replicas, and a basic periodontal examination set (exploratory probe, periodontal probe, Nabers probe, mirror). and tweezers).
- Evaluation of experimental and statistical results (3 lines) -
The data obtained will be analyzed through a descriptive statistical analysis (mean, median and standard deviations). The qualitative variables will be expressed in frequencies and percentages. In addition, logistic regression analyzes will be performed to determine the association between peri-implant status (at the implant and patient level) and the angle/emergence of implant-supported prostheses.
- Conditions
- Peri-Implantitis
- Being tested
- No intervention
- Keywords
- Dental Implant, Dental prosthesis, Implant-supported, Prevalence, Risk factors
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the influence of excessively contour or overcontoured restorations
Defined as those that present an emergency profile with a marked emergency angle and/or convex profile evaluated by intraoral scanning, in the risk of suffering from peri-implant diseases
Measured: February 2021 - may 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start5 May 2021
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramón Pons Calabuig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramón Pons Calabuig, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592314
- Sponsor's protocol ID
- PER-ECL-2020-09a
- Status last verified
- Mar 2025
- First submitted
- 19 Oct 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05592314
- Acronym / sponsor ID
- PER-ECL-2020-09a
- Conditions
- Peri-Implantitis
- Keywords
- Dental Implant, Dental prosthesis, Implant-supported, Prevalence, Risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ramón Pons CalabuigUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Oct 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.
- Objectives: To evaluate the influence of the shape and contour of implant-supported restorations on peri-implant soft and hard tissues by using an intraoral scanner.
- Material and methods:
- Number of patients to be treated: 120
- Number of visits per patient: 1
- Brief description of the different techniques used in the study, authorized and validated in the literature (3-5 lines). A clinical and radiographic evaluation of the dental implants of those patients who are undergoing maintenance therapy treated by the Department of Periodontics of the International University of Catalonia prior to 2017 will be carried out. Additionally, a digital scan of the crown will be carried out using a intraoral scanner. Finally, patients will fill out a questionnaire about their routine dental care.
- Benefits and harms of participating in the study for the patient Participating in this study implies irradiating the patient through a periapical x-ray in order to assess the bone level of their implants and therefore be able to diagnose the presence or absence of peri-implant disease. Regarding the possible benefits, the patient will help the scientific community to determine the ideal contour and shape of the implant-supported restoration that will prevent the appearance of peri-implant diseases. Likewise, patients will undergo an exhaustive clinical and radiographic review that will allow their dental and periodontal status to be updated.
- Alternative treatment in case the patient does not wish to participate in the clinical study As this is an observational study, there is no alternative treatment. The patient will have absolute freedom to decline to participate in the study.
- Treatment to be carried out in the event that complications arise in the patient, once the clinical study has begun If after handling the prosthesis, it is detected that any of the screws that support the prostheses are loose or defective, the MORE department will be informed in order to replace said accessory. On the other hand, they would be informed in the same way in case of detecting any complication/alteration with the patient's implant-supported crowns.
- Material needed to carry out the study ( To carry out this study, you will need posterior radiographic positioners, radiographs, an intraoral scanner (3Shape Trios®), the implant analogs or replicas, and a basic periodontal examination set (exploratory probe, periodontal probe, Nabers probe, mirror). and tweezers).
- Evaluation of experimental and statistical results (3 lines) -
The data obtained will be analyzed through a descriptive statistical analysis (mean, median and standard deviations). The qualitative variables will be expressed in frequencies and percentages. In addition, logistic regression analyzes will be performed to determine the association between peri-implant status (at the implant and patient level) and the angle/emergence of implant-supported prostheses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient presents at least one implant-supported restoration in the posterior region (molars and premolars), placed at the university between 2010 and 2017.
Key inclusion criteria (5 listed)
- Patients aged 18-80 years,
- Implant properly positioned (≥ 2 mm from the buccal plate and >1 mm from the lingual plate or in the ideal occlusal plane horizontally, 5 to 2 mm from the adjacent CEJ or from 2 mm below the residual ridge to crestal position (0 mm) apico-coronally and with an angulation of 70 to 90 degrees from the adjacent tooth long axis or from the ridge parallelism) (21),
- Implant loading for more than 3 years,
- Partial or total edentulism being restored with dental implants in the molar and premolar region with single or partial restorations.
- Patients who have not taken any antibiotic and regular NSAIDs in the last 2 months prior to the clinical examination,
Key exclusion criteria (8 listed)
- Uncontrolled systemic diseases (i.e., diabetes mellitus)
- Pregnancy or lactation patients,
- Smokers of ≥10 cig/day.
- Zygomatic or pterygoid implants,
- Removable prostheses and cement-retained implant prostheses,
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Evaluate the influence of excessively contour or overcontoured restorations
Time frame: February 2021 - may 2023
Defined as those that present an emergency profile with a marked emergency angle and/or convex profile evaluated by intraoral scanning, in the risk of suffering from peri-implant diseases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Ramón Pons Calabuig at 1 site in Spain.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leire Izaskun, DDS (628362896, leiizas@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the influence of excessively contour or overcontoured restorations (time frame: February 2021 - may 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.