Peri-ImplantitisNCT06049121
In Vivo Biofilm Accumulation on Implants With 3 Different Surfaces
An observational study of Peri-Implantitis, run by Malmö University at 1 site in Sweden.
Trial summary
A frequent sequela of peri-implantitis itself, but also of its surgery, is the exposure of the implant surface to the oral environment. This moderately-rough surface with threads, when exposed to the oral environment, is difficult to clean. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2023to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited at the Faculty of Odontology of Malmö University after informed consent is obtained
Who may be able to join
- adults, > 18 years old
- systemically healthy
- full mouth healthy periodontal conditions
Who cannot join
- current pregnancy or breastfeeding
- heavy smokers (> 10 cigarettes per day)
- antibiotic intake in the previous 3 months
- orthodontic appliances in the upper jaw
- removable prosthesis in the upper jaw
- extensive implant-supported restorations in the upper jaw
- active carious lesions
Trial locations and contacts
1 site in 1 country.
About this study
A frequent sequela of peri-implantitis itself, but also of its surgery, is the exposure of the implant surface to the oral environment. This moderately-rough surface with threads, when exposed to the oral environment, is difficult to clean. Therefore, in cases where the implant surface is expected to remain exposed or to be in direct contact with the peri-implant mucosa, implantoplasty has been proposed to obtain a smoother surface. A smoother surface should allow more efficient plaque control. This in vivo study aims to evaluate potential differences in terms of plaque accumulation between 3 different implant surfaces.
Ten participants will wear the removable splint carrying 2 implants of each type of surface (i.e., turned, modified, and modified treated with implantoplasty) for 3 days and they will be asked to remove it to perform their (usual) oral hygiene and immerse the device in cold-tap water. On day 3, the removable splint will be collected for analysis. The area of biofilm covering the implants will be quantified with different methods.
Read the detailed description
The aim of this in vivo study is to evaluate potential differences in terms of plaque accumulation among 3 different implant surfaces (i.e., turned, modified, and modified treated with implantoplasty).
Splint fabrication At the first visit, a maxillary alginate impression and a gypsum cast will be produced for every participant. This cast will be used to build a removable vacuum splint, which in turn will allow to carry six implants during the study period (i.e., 2 implants of each group T, M, I). Both on the right- and left-buccal aspects of the cast, three implants (i.e., 1 implant of each group T, M, I) will be randomly allocated and secured in their position prior to making the vacuum splint. The splint will be individually trimmed and polished to provide both retention and comfort.
At the second visit, splints will be tried and, if necessary, adjusted to avoid any discomfort. Participants will be instructed in detail on how to wear and handle the splint.
At the third visit, splints will be collected and stored for analyses.
Sample size calculation The only previous study with a similar study design (Azzola et al., 2020) included only a single participant. Based on the presented data of this specific study and due to the large difference between the test and control group, a reasonable sample size calculation was not feasible. Thus, a sample size of 10 participants was arbitrarily chosen for the present study.
Ethical Considerations All splints will be individually adapted, and implants will be fixated on the buccal aspect to avoid any interference while speaking. Also, mucosal and gingival irritation will be avoided by polishing the splints on the edges and keeping a distance from the gingival margin. Further, as participants will be instructed to remove the splint to brush and floss their teeth on a regular basis, there will be no increased risk of caries or gingivitis due to biofilm accumulation during the 3-day study period.
- Conditions
- Peri-Implantitis
- Keywords
- Biofilm, Peri-implantitis, In vivo, Implantoplasty
- Medical subject headings
- Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of the biofilm
Quantification with crystal violet biofilm quantification assay
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start4 Oct 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Stavropoulos, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049121
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertl K, Al-Said M, Mourad A, Mayol M, Lopes da Silva Z, Papia E, Stavropoulos A. Reduced Biofilm Accumulation on Implants Treated With Implantoplasty-An In Situ Trial With a Within-Subject Comparison. Clin Exp Dent Res. 2024 Dec;10(6):e70043. doi: 10.1002/cre2.70043.
PubMed 39610010
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Biofilm Accumulation on Implants With 3 Different Surfaces
- ClinicalTrials.gov ID
- NCT06049121
- Acronym / sponsor ID
- 1
- Conditions
- Peri-Implantitis
- Keywords
- Biofilm, Peri-implantitis, In vivo, Implantoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Sep 2023 (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.
A frequent sequela of peri-implantitis itself, but also of its surgery, is the exposure of the implant surface to the oral environment. This moderately-rough surface with threads, when exposed to the oral environment, is difficult to clean. Therefore, in cases where the implant surface is expected to remain exposed or to be in direct contact with the peri-implant mucosa, implantoplasty has been proposed to obtain a smoother surface. A smoother surface should allow more efficient plaque control. This in vivo study aims to evaluate potential differences in terms of plaque accumulation between 3 different implant surfaces.
Ten participants will wear the removable splint carrying 2 implants of each type of surface (i.e., turned, modified, and modified treated with implantoplasty) for 3 days and they will be asked to remove it to perform their (usual) oral hygiene and immerse the device in cold-tap water. On day 3, the removable splint will be collected for analysis. The area of biofilm covering the implants will be quantified with different methods.
Detailed description
The aim of this in vivo study is to evaluate potential differences in terms of plaque accumulation among 3 different implant surfaces (i.e., turned, modified, and modified treated with implantoplasty).
Splint fabrication At the first visit, a maxillary alginate impression and a gypsum cast will be produced for every participant. This cast will be used to build a removable vacuum splint, which in turn will allow to carry six implants during the study period (i.e., 2 implants of each group T, M, I). Both on the right- and left-buccal aspects of the cast, three implants (i.e., 1 implant of each group T, M, I) will be randomly allocated and secured in their position prior to making the vacuum splint. The splint will be individually trimmed and polished to provide both retention and comfort.
At the second visit, splints will be tried and, if necessary, adjusted to avoid any discomfort. Participants will be instructed in detail on how to wear and handle the splint.
At the third visit, splints will be collected and stored for analyses.
Sample size calculation The only previous study with a similar study design (Azzola et al., 2020) included only a single participant. Based on the presented data of this specific study and due to the large difference between the test and control group, a reasonable sample size calculation was not feasible. Thus, a sample size of 10 participants was arbitrarily chosen for the present study.
Ethical Considerations All splints will be individually adapted, and implants will be fixated on the buccal aspect to avoid any interference while speaking. Also, mucosal and gingival irritation will be avoided by polishing the splints on the edges and keeping a distance from the gingival margin. Further, as participants will be instructed to remove the splint to brush and floss their teeth on a regular basis, there will be no increased risk of caries or gingivitis due to biofilm accumulation during the 3-day study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited at the Faculty of Odontology of Malmö University after informed consent is obtained
Key inclusion criteria (3 listed)
- adults, > 18 years old
- systemically healthy
- full mouth healthy periodontal conditions
Key exclusion criteria (7 listed)
- current pregnancy or breastfeeding
- heavy smokers (> 10 cigarettes per day)
- antibiotic intake in the previous 3 months
- orthodontic appliances in the upper jaw
- removable prosthesis in the upper jaw
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quantification of the biofilm
Time frame: 3 days
Quantification with crystal violet biofilm quantification assay
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 9 Jul 2024.
- Derived from this study: PubMed 39610010Bertl K, Al-Said M, Mourad A, Mayol M, Lopes da Silva Z, Papia E, Stavropoulos A. Reduced Biofilm Accumulation on Implants Treated With Implantoplasty-An In Situ Trial With a Within-Subject Comparison. Clin Exp Dent Res. 2024 Dec;10(6):e70043. doi: 10.1002/cre2.70043.
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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 Malmö University at 1 site in Sweden.
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 3 inclusion and 7 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 9 Jul 2024. 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 Sweden. 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?
quantification of the biofilm (time frame: 3 days). 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 NCT06049121, 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 9 Jul 2024.