- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900297
Antibiotic Regimen for Dental Implants Cases
Antibiotic Regimen for Patients Seeking Dental Implants Procedures
This study aims to:
- To identify the most common organisms causing dental implant failure.
- Set an appropriate antibiotic regimen according to the causative organism to limit the antimicrobial resistance by limit the use of antibiotics.
Study Overview
Status
Conditions
Detailed Description
Dental implant surgery is a common treatment for replacing missing teeth and has a high success rate. Implant failure is most likely the result of multiple factors as Age, sex, smoking, maxillary implant site, quantity and quality of bone, implant surface treatments and features are some of the statistically examined parameters linked to implant failure. The most frequent and avoidable cause of dental implant failure is infection. A retrospective analysis demonstrated fewer numbers of early implant failures among those that were placed under antibiotic treatments.
Early implant failure is commonly associated with certain strains of bacteria. The most common bacteria involved are streptococci, anaerobic Gram-positive cocci, and anaerobic Gram-negative rods.Porphyromonas gingivalis and Fusobacterium nucleatum frequently colonize the implant in early and late losses and could therefore be characteristic for implant loss in general.
Thus, the antibiotic to prevent delayed healing of wound should be bactericidal and of low toxicity. Systemic antibiotic prophylaxis has been used to reduce the risk of early implant failure and local infections around dental implants.Antibiotics are one of the most cost-effective, life-saving medicines and contribute to an extended lifespan. Access to antibiotics without a prescription is a driving factor for irrational antibiotic use due to a potential lack of access to proper diagnosis and diagnostic tools. This eventually leads to the development and spread of antibiotic resistance &it is one of the increasing public health challenges worldwide.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: salma mohamed, master
- Phone Number: +201093128009
- Email: salma_essam_91@hotmail.com
Study Contact Backup
- Name: heba rashed, professor
- Phone Number: +201003997231
- Email: hebager@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Saliva samples from patients seeking dental implant procedures
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Exclusion Criteria:
- Immunodeficiency or immunosuppressing treatment
- current antibiotic treatment
- smoking
- acute or chronic oral infection (including ongoing periodontal infection).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to limit the antimicrobial resistance by identifying the most suitable antibiotic regimen according to the intra-oral organisms
Time Frame: september 2023-september 2024
|
according to the antibiogram at least 30 isolates from each species are needed to identify the most common organisms and set an appropriate antibiotic regimen for patients seeking dental implants.An antibiogram is an overall profile of antimicrobial susceptibility testing results of a specific microorganism to a battery of antimicrobial drugs.
This profile is generated by the laboratory using aggregate data from a hospital or healthcare system; data are summarized periodically and presented showing percentages of organisms tested that are susceptible to a particular antimicrobial drug
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september 2023-september 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to prevent dental implant failure by setting the most suitable antibiotic regimen according to the intra-oral micro-organisms
Time Frame: through the study completion, an average of one year.
|
the investigator can define and set antibiotic regimen to the oral micro-organisms by the antibiogram .The Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS) published guidelines entitled "Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data" for use when creating an antibiogram.
CLSI guidelines recommend compiling the antibiogram at least annually, including only the first isolate per patient in the period analyzed, and including only organisms for which ≥30 isolates were tested in the period analyzed.
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through the study completion, an average of one year.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Kochar SP, Reche A, Paul P. The Etiology and Management of Dental Implant Failure: A Review. Cureus. 2022 Oct 19;14(10):e30455. doi: 10.7759/cureus.30455. eCollection 2022 Oct.
- Surapaneni H, Yalamanchili PS, Basha MH, Potluri S, Elisetti N, Kiran Kumar MV. Antibiotics in dental implants: A review of literature. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S28-S31. doi: 10.4103/0975-7406.191961.
- Machowska A, Stalsby Lundborg C. Drivers of Irrational Use of Antibiotics in Europe. Int J Environ Res Public Health. 2018 Dec 23;16(1):27. doi: 10.3390/ijerph16010027.
- Momand P, Becktor JP, Naimi-Akbar A, Tobin G, Gotrick B. Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial. Clin Implant Dent Relat Res. 2022 Feb;24(1):116-124. doi: 10.1111/cid.13068. Epub 2022 Jan 24.
- Korsch M, Marten SM, Stoll D, Prechtl C, Dotsch A. Microbiological findings in early and late implant loss: an observational clinical case-controlled study. BMC Oral Health. 2021 Mar 11;21(1):112. doi: 10.1186/s12903-021-01439-w.
- Bernabeu-Mira JC, Penarrocha-Diago M, Penarrocha-Oltra D. Prescription of Antibiotic Prophylaxis for Dental Implant Surgery in Healthy Patients: A Systematic Review of Survey-Based Studies. Front Pharmacol. 2021 Feb 10;11:588333. doi: 10.3389/fphar.2020.588333. eCollection 2020.
- Antwi AN, Stewart A, Crosbie M. Fighting antibiotic resistance: a narrative review of public knowledge, attitudes, and perceptions of antibiotics use. Perspect Public Health. 2020 Nov;140(6):338-350. doi: 10.1177/1757913920921209. Epub 2020 Jun 9.
- Pyysalo M, Helminen M, Antalainen AK, Sandor GK, Wolff J. Antibiotic prophylaxis patterns of Finnish dentists performing dental implant surgery. Acta Odontol Scand. 2014 Nov;72(8):806-10. doi: 10.3109/00016357.2014.913194. Epub 2014 May 5.
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- antibiotic for dental implants
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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