- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049121
In Vivo Biofilm Accumulation on Implants With 3 Different Surfaces
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andreas Stavropoulos
- Phone Number: +46406657000
- Email: andreas.stavropoulos@mau.se
Study Locations
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Malmö, Sweden, 20506
- Recruiting
- Malmö University
-
Contact:
- Andreas Stavropoulos, Prof.
- Email: andreas.stavropoulos@mau.se
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults, > 18 years old
- systemically healthy
- full mouth healthy periodontal conditions
Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quantification of the biofilm
Time Frame: 3 days
|
Quantification with crystal violet biofilm quantification assay
|
3 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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