Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components
1 other identifier
interventional
17
1 country
1
Brief Summary
This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion. The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Typical duration for not_applicable
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
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedStudy Start
First participant enrolled
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedFebruary 25, 2025
February 1, 2025
2.4 years
May 30, 2018
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
24 hours
Total amount of the 25 most relevant bacterial species in peri-implantitis processes
2 months
Secondary Outcomes (5)
Total number of bacterial species.
24 hours, 2 months
Total amount of the 6 most abundant bacterial species.
24 hours, 2 months
Dental plaque index
Baseline, 24 hours, 2 months
Gingival index of the natural teeth
Baseline, 24 hours, 2 months
Probing depth of natural teeth
Baseline, 24 hours, 2 months
Study Arms (3)
Multi-Im Machined
ACTIVE COMPARATORMulti-Im Machined
Multi-Im® nanogolden
EXPERIMENTALMulti-Im® nanogolden
Multi-Im T-Golden
EXPERIMENTALMulti-Im T-Golden
Interventions
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM machined transepithelial component is connected to the implant.
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Nanogolden transepithelial component is connected to the implant.
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Ti-Golden transepithelial component is connected to the implant.
Eligibility Criteria
You may qualify if:
- Indication of having to place at least three dental implants.
- Plate index ≤ 20% and absence of evidence of active periodontal disease.
- Bleeding index of adjacent teeth ≤ 30%.
- Probing depth in adjacent teeth \<4 mm.
- Not having used systemic antibiotics during the last 6 months.
- Non smoker.
- Possibility for observation during the treatment period.
- Having signed the informed consent.
You may not qualify if:
- Suffering any alteration or serious hematologic disease.
- radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants.
- Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement.
- Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously.
- Metabolic bone disease.
- Diseases that affect the oral mucosa.
- Diabetic patients.
- Severe parafunctional habits and/or temporomandibular joint disorders.
- Pregnant or lactating women.
- Physical or mental inability to maintain a good oral hygiene.
- Being participating in another study.
- In general, any inability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clínica Eduardo Anitua
Vitoria-Gasteiz, Spain
Related Publications (1)
Anitua E, Murias-Freijo A, Tierno R, Tejero R, Alkhraisat MH. Assessing peri-implant bacterial community structure: the effect of microbiome sample collection method. BMC Oral Health. 2024 Aug 26;24(1):1001. doi: 10.1186/s12903-024-04675-y.
PMID: 39187802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2018
First Posted
June 13, 2018
Study Start
July 16, 2018
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
February 25, 2025
Record last verified: 2025-02