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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Malmö University

Malmö, 20506, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

quantification of the biofilm

Time frame: 3 days

Quantification with crystal violet biofilm quantification assay

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Sep 21, 2023
Registry last updated: Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed