In Vivo Biofilm Accumulation on Implants With 3 Different Surfaces
1 other identifier
observational
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 9, 2024
July 1, 2024
3 months
September 15, 2023
July 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quantification of the biofilm
Quantification with crystal violet biofilm quantification assay
3 days
Eligibility Criteria
Participants recruited at the Faculty of Odontology of Malmö University after informed consent is obtained
You may qualify if:
- adults, \> 18 years old
- systemically healthy
- full mouth healthy periodontal conditions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malmö Universitylead
Study Sites (1)
Malmö University
Malmo, 20506, Sweden
Related Publications (1)
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.
PMID: 39610010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 15, 2023
First Posted
September 21, 2023
Study Start
October 4, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 9, 2024
Record last verified: 2024-07