Peri-Implantitis Clinical Trial
Official title:
Antiseptic Effects on the Dental Implant Internal Surface Microbiome
Soldiers operate in environments that are more likely to lead to oral trauma, risking poor dentition which can directly impact military readiness. Dental restoration can often be accomplished via dental implant insertion. Microbiome-associated complications that result in bone loss, including the micro-leakage of bacterial species proliferating in the dental implant internal cavity, frequently lead to implant failure. Reduction in implant bacterial load may result in a shift of the composition of the microbiome in favor of less pathogenic species, potentially improving dental implant success rates, reducing surgical revisions, and associated cost savings. This study aims to determine how disinfectant gel (hydrogen peroxide or chlorhexidine) insertion into dental implant internal cavities affects implant failure rates, bacterial load and microbiome composition.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Active duty military - 18-55 years old - Over 6 months remaining at local duty station Exclusion Criteria: - Tobacco user - Medications that affect soft tissue or bone healing - Metabolic disorder that affects soft tissue or bone healing - Active periodontal disease |
Country | Name | City | State |
---|---|---|---|
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Madigan Army Medical Center | United States Department of Defense |
United States,
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Paolantonio M, Perinetti G, D'Ercole S, Graziani F, Catamo G, Sammartino G, Piccolomini R. Internal decontamination of dental implants: an in vivo randomized microbiologic 6-month trial on the effects of a chlorhexidine gel. J Periodontol. 2008 Aug;79(8):1419-25. doi: 10.1902/jop.2008.070660. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant Failure | We will compare the rates of dental implant failure between study arms. | Four months post dental implant insertion. | |
Secondary | Peri-Implantitis | We will compare the rates of peri-implantitis between study arms. | Four months post dental implant insertion. | |
Secondary | Bacterial Load | We will compare the bacterial load in the dental implant internal cavity between study arms. | Four months post dental implant insertion. | |
Secondary | Microbiome Composition | We will compare the relative abundance of red and orange complex bacteria in the dental implant internal cavity between study arms. | Four months post dental implant insertion. |
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