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Dental Implant InfectionNCT05900297

Antibiotic Regimen for Dental Implants Cases

An observational study of Dental Implant Infection, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to: 1. To identify the most common organisms causing dental implant failure. 2. Set an appropriate antibiotic regimen according to the causative organism to limit the antimicrobial resistance by limit the use of antibiotics. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dental Implant Infection
How many people
100 participants
Where
No sites listed yet
Study dates
15 Sep 2023to 20 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: patients seeking dental implant procedures

Who may be able to join

None listed.

Who cannot join

  • Immunodeficiency or immunosuppressing treatment
  • current antibiotic treatment
  • smoking
  • acute or chronic oral infection (including ongoing periodontal infection).

Trial locations and contacts

No sites are listed yet.

salma mohamed, master contact

+201093128009

salma_essam_91@hotmail.com

heba rashed, professor contact

+201003997231

hebager@yahoo.com

About this study

Official title: Antibiotic Regimen for Patients Seeking Dental Implants Procedures

This study aims to:

  1. To identify the most common organisms causing dental implant failure.
  2. Set an appropriate antibiotic regimen according to the causative organism to limit the antimicrobial resistance by limit the use of antibiotics.
Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to limit the antimicrobial resistance by identifying the most suitable antibiotic regimen according to the intra-oral organisms

    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

    Measured: september 2023-september 2024

Secondary outcomes (1)

  1. to prevent dental implant failure by setting the most suitable antibiotic regimen according to the intra-oral micro-organisms

    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.

    Measured: through the study completion, an average of one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start15 Sep 2023 (estimated)
  3. Primary completion15 Sep 2024 (estimated)
  4. Study completion20 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900297
Sponsor's protocol ID
antibiotic for dental implants
Status last verified
Jun 2023
First submitted
27 May 2023
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36415394

  • 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.

    PubMed 27829741

  • 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.

    PubMed 30583571

  • 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.

    PubMed 35075765

  • 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.

    PubMed 33706748

  • 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.

    PubMed 33643035

  • 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.

    PubMed 32515278

  • 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.

    PubMed 24791607

  • 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.

    PubMed 3507627

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Implant Infection, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact salma mohamed, master (+201093128009, salma_essam_91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to limit the antimicrobial resistance by identifying the most suitable antibiotic regimen according to the intra-oral organisms (time frame: september 2023-september 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900297, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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