Antibiotic Resistant StrainNCT04795518
The Pattern of Antibiotic Prescription for Children Among a Group of Pediatric Dentists.
An observational study of Antibiotic Resistant Strain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the pattern of antibiotic prescription for children among a group of pediatric dentists Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Antibiotic Resistant Strain
- How many people
- 334 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jun 2022
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Group of pediatric dentists
Who may be able to join
- Dentists of pediatric dentistry working for children aged. Dentists who have BDS degree in the last 20 years.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, 11562
Ahmed M EL-Gendy, BDS, 00201092524899, ahmed_abdo@dentistry.cu.edu.eg
Fatma Kl Abdegawad, PhD, 00201006753265, fatma.abdelgawad@dentistry.cu.edu.eg
About this study
The aim of this study is to determine the pattern of antibiotic prescription for children among a group of pediatric dentists
Read the detailed description
Antibiotic prescriptions for children is a cause for concern in both developed and developing countries, especially for its excessive use in non-established infections or in infections with viral etiology (Friedman et al., 2011). Although antibiotics play a crucial role in reducing child morbidity and mortality (De Jong et al., 2009), its irrational use directly increases antibiotic resistance by promoting the emergence of resistant bacteria leading to increased rates of treatment failures and more severe illness episodes with higher costs and mortality rates (Adisa et al., 2018).
Rational prescribing implies using the right drug for the right patient at the right time in the right dose and manner of administration at affordable cost with the right information. Thus, rational antibiotic prescription has to be tailor-made for individual patients taking into account the diagnosis, age, sex, weight, microorganism susceptibility, vital organ functions, drug and food interactions, as well as socioeconomic background of a patient (Aronson, 2014).
Within the dental community, awareness of clinical indications of antibiotic prescriptions to the child dental patient is lacking. It was found that a substantial proportion of children who received dental treatment for pain or localized swelling under general anaesthesia had also received antibiotics, with wide variation in antibiotic regimens (Dar-Odeh et al., 2018). Further, among members of the American Academy of Pediatric Dentistry, there was a trend toward overuse of antibiotics for non-indicated clinical conditions, like pain relief, irreversible pulpitis, and localized dentoalveolar abscess (Sivaraman et al., 2013).
Conditions requiring antibiotic treatment in dentistry is limited and there should be (i) a therapeutic goal to help treatment of acute/chronic infections (where drainage or debridement is impossible) or (ii) a prophylactic goal to prevent metastatic infections (e.g., bacterial endocarditis) or local or systemic spread of the infection (Dar-Odeh et al., 2010).
The non-clinical factors initiated antibiotic prescribing for some clinicians, such as unavailability of close appointments and seeking parental satisfaction (Sivaraman et al., 2013). A similar trend was observed in developing countries, where a substantial proportion of dentists prescribe for non-indicated clinical conditions, such as dry socket, localized periapical infection, marginal gingivitis, periodontitis, and pulpitis (Kouidhi et al., 2011). This insufficient knowledge of the appropriate clinical indications is paralleled by a lack of awareness of important interventions that promote the optimal use of antibiotics, such as antibiotic stewardship programs. Other forms of abuse in prescribing antibiotics include prescribing broad-spectrum antibiotics for infections that can be treated by narrow-spectrum antibiotics, prescribing antibiotics for long periods, and adopting inappropriate dosing regimens (Sivaraman et al., 2013).
Patients who consult their GP due to tooth-related problems are unlikely to receive a surgical intervention and have a greater likelihood of being prescribed a systemic antibiotic compared to individuals who consult a dentist with similar symptoms (Cope et al., 2015)complications from an odontogenic infection, (Seppänen et al., 2011) the management of dental problems in general practice could result in increased patient morbidity. Furthermore, the indiscriminate use of antibiotics may contribute to the emergence of antibiotic-resistant bacterial strains (Cope et al., 2015).
Antibiotic resistance (AR) is a condition when bacteria change against antibiotics which are developed to cure the illnesses they cause. It is a global crisis and posed as one of the greatest threats to population health. This problem is driven by many factors such as low quality of antibiotics and improper (under- or over-) use of antibiotics (including self-medication) (Alumran et al., 2013). Self-medication, which refers to the use of any medical products without a prescription or following unprofessional recommendations in treating any illnesses (Togoobaatar et al., 2010), is particularly leading to the AR. Self-medication practice possibly raises incorrect drug selection, drug resistance, uncontrolled adverse effects or drug reactions, misdiagnosis, and delay in medical care (El-Hawy et al., 2017).
It has been observed that contribute to the problem of antibiotic resistance by dentists can be substantial as dentists prescribe 10% of all common antibiotics. Yingling et al concluded from the findings of his study among members of the American Association of Endodontists (AAE) that they were prescribing antibiotics inappropriately. On the contrary (Yingling et al., 2002), the National Center for Disease Control and Prevention found that almost one-third of all outpatient antibiotic prescriptions are unnecessary (Swift and Gulden, 2002). The world has entered an era where some bacterial species are resistant to the full range of antibiotics presently available, with the methicillin-resistant Staphylococcus aureus and vancomycin-resistant Staphylococcus aureus being the most widely known example of extensive resistance (Lewis, 2008).
It is estimated that, in 2050, there will be more than 10 million deaths and 100 trillion USD lost due to AR if no substantial actions have been made to eliminate this emerging threat. As inappropriate antibiotic use is the primary cause of AR, responses to this phenomenon prioritize promoting public awareness about AR (El-Hawy et al., 2017).
Irrational prescribing can be due to errors such as required amount of drug or as errors in writing, abbreviations, pharmaceutical form, drug dosage, administration method, or duration of treatment. These errors can lead to ineffective treatment and dangerous, long-lasting illness, or worse: harm to the patient and an increase of the cost of treatment (Grant et al., 2013).
Dentists, like other health care practitioners should have sufficient knowledge about drugs. Observing the prescription principles according to international law for dentists is required. Although dental prescription generally contain pharmaceutics items are limited to providing short-term drug therapy or specific drugs prescribed for dental surgeries but the evidence suggests that in many countries, dentists often do not enjoy a good medical knowledge for this reason, some mistakes in writing prescription occurred (Guzmán-Álvarez et al., 2012).
Goud et al. reported that general dentists prescribed more than required antibiotics for root canal therapy (Goud et al., 2012). Mendonca et al. found that in one-fourth of prescriptions written by dentists, medication names were illegible (Mendonça et al., 2010). Ogunbodede et al findings indicate the presence of different types of error in dentist's prescription in term of dosing, frequency and duration of drug use (Ogunbodede et al., 2005).
- Conditions
- Antibiotic Resistant Strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross sectional study by questionnaire among group of pediatric dentistry | An interviewed questionnaire is divided into two parts. The first part of the questionnaire will investigate the socio-demographic characteristics of the respondents. The second part of the questionnaire is divided into five sections to cover the following items: 1. Use of antibiotics pattern 2. Knowledge about antibiotics 3. Sources of information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of antibiotic prescription in children
Questionnaire (Kaul et al., 2018), Multiple choice question
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant StrainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mostafa abdo elgendy, Cairo University
- Investigators
- ahmed M EL-Gendy, BDS, Principal investigator, Dentist at Ministry of Health,EGYPTFatma Kl EL-Gendy, PhD, Study chair, Assistant Professor at Pediatric Dentistry and Dental Public Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795518
- Sponsor's protocol ID
- antibiotic misues
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaul R, Angrish P, Jain P, Saha S, V Sengupta A, Mukherjee S. A Survey on the Use of Antibiotics among the Dentists of Kolkata, West Bengal, India. Int J Clin Pediatr Dent. 2018 Mar-Apr;11(2):122-127. doi: 10.5005/jp-journals-10005-1497. Epub 2018 Apr 1.
PubMed 29991865
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pattern of Antibiotic Prescription for Children Among a Group of Pediatric Dentists.
- ClinicalTrials.gov ID
- NCT04795518
- Acronym / sponsor ID
- antibiotic misues
- Conditions
- Antibiotic Resistant Strain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the pattern of antibiotic prescription for children among a group of pediatric dentists
Detailed description
Antibiotic prescriptions for children is a cause for concern in both developed and developing countries, especially for its excessive use in non-established infections or in infections with viral etiology (Friedman et al., 2011). Although antibiotics play a crucial role in reducing child morbidity and mortality (De Jong et al., 2009), its irrational use directly increases antibiotic resistance by promoting the emergence of resistant bacteria leading to increased rates of treatment failures and more severe illness episodes with higher costs and mortality rates (Adisa et al., 2018).
Rational prescribing implies using the right drug for the right patient at the right time in the right dose and manner of administration at affordable cost with the right information. Thus, rational antibiotic prescription has to be tailor-made for individual patients taking into account the diagnosis, age, sex, weight, microorganism susceptibility, vital organ functions, drug and food interactions, as well as socioeconomic background of a patient (Aronson, 2014).
Within the dental community, awareness of clinical indications of antibiotic prescriptions to the child dental patient is lacking. It was found that a substantial proportion of children who received dental treatment for pain or localized swelling under general anaesthesia had also received antibiotics, with wide variation in antibiotic regimens (Dar-Odeh et al., 2018). Further, among members of the American Academy of Pediatric Dentistry, there was a trend toward overuse of antibiotics for non-indicated clinical conditions, like pain relief, irreversible pulpitis, and localized dentoalveolar abscess (Sivaraman et al., 2013).
Conditions requiring antibiotic treatment in dentistry is limited and there should be (i) a therapeutic goal to help treatment of acute/chronic infections (where drainage or debridement is impossible) or (ii) a prophylactic goal to prevent metastatic infections (e.g., bacterial endocarditis) or local or systemic spread of the infection (Dar-Odeh et al., 2010).
The non-clinical factors initiated antibiotic prescribing for some clinicians, such as unavailability of close appointments and seeking parental satisfaction (Sivaraman et al., 2013). A similar trend was observed in developing countries, where a substantial proportion of dentists prescribe for non-indicated clinical conditions, such as dry socket, localized periapical infection, marginal gingivitis, periodontitis, and pulpitis (Kouidhi et al., 2011). This insufficient knowledge of the appropriate clinical indications is paralleled by a lack of awareness of important interventions that promote the optimal use of antibiotics, such as antibiotic stewardship programs. Other forms of abuse in prescribing antibiotics include prescribing broad-spectrum antibiotics for infections that can be treated by narrow-spectrum antibiotics, prescribing antibiotics for long periods, and adopting inappropriate dosing regimens (Sivaraman et al., 2013).
Patients who consult their GP due to tooth-related problems are unlikely to receive a surgical intervention and have a greater likelihood of being prescribed a systemic antibiotic compared to individuals who consult a dentist with similar symptoms (Cope et al., 2015)complications from an odontogenic infection, (Seppänen et al., 2011) the management of dental problems in general practice could result in increased patient morbidity. Furthermore, the indiscriminate use of antibiotics may contribute to the emergence of antibiotic-resistant bacterial strains (Cope et al., 2015).
Antibiotic resistance (AR) is a condition when bacteria change against antibiotics which are developed to cure the illnesses they cause. It is a global crisis and posed as one of the greatest threats to population health. This problem is driven by many factors such as low quality of antibiotics and improper (under- or over-) use of antibiotics (including self-medication) (Alumran et al., 2013). Self-medication, which refers to the use of any medical products without a prescription or following unprofessional recommendations in treating any illnesses (Togoobaatar et al., 2010), is particularly leading to the AR. Self-medication practice possibly raises incorrect drug selection, drug resistance, uncontrolled adverse effects or drug reactions, misdiagnosis, and delay in medical care (El-Hawy et al., 2017).
It has been observed that contribute to the problem of antibiotic resistance by dentists can be substantial as dentists prescribe 10% of all common antibiotics. Yingling et al concluded from the findings of his study among members of the American Association of Endodontists (AAE) that they were prescribing antibiotics inappropriately. On the contrary (Yingling et al., 2002), the National Center for Disease Control and Prevention found that almost one-third of all outpatient antibiotic prescriptions are unnecessary (Swift and Gulden, 2002). The world has entered an era where some bacterial species are resistant to the full range of antibiotics presently available, with the methicillin-resistant Staphylococcus aureus and vancomycin-resistant Staphylococcus aureus being the most widely known example of extensive resistance (Lewis, 2008).
It is estimated that, in 2050, there will be more than 10 million deaths and 100 trillion USD lost due to AR if no substantial actions have been made to eliminate this emerging threat. As inappropriate antibiotic use is the primary cause of AR, responses to this phenomenon prioritize promoting public awareness about AR (El-Hawy et al., 2017).
Irrational prescribing can be due to errors such as required amount of drug or as errors in writing, abbreviations, pharmaceutical form, drug dosage, administration method, or duration of treatment. These errors can lead to ineffective treatment and dangerous, long-lasting illness, or worse: harm to the patient and an increase of the cost of treatment (Grant et al., 2013).
Dentists, like other health care practitioners should have sufficient knowledge about drugs. Observing the prescription principles according to international law for dentists is required. Although dental prescription generally contain pharmaceutics items are limited to providing short-term drug therapy or specific drugs prescribed for dental surgeries but the evidence suggests that in many countries, dentists often do not enjoy a good medical knowledge for this reason, some mistakes in writing prescription occurred (Guzmán-Álvarez et al., 2012).
Goud et al. reported that general dentists prescribed more than required antibiotics for root canal therapy (Goud et al., 2012). Mendonca et al. found that in one-fourth of prescriptions written by dentists, medication names were illegible (Mendonça et al., 2010). Ogunbodede et al findings indicate the presence of different types of error in dentist's prescription in term of dosing, frequency and duration of drug use (Ogunbodede et al., 2005).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross sectional study by questionnaire among group of pediatric dentistry | – | –An interviewed questionnaire is divided into two parts. The first part of the questionnaire will investigate the socio-demographic characteristics of the respondents. The second part of the questionnaire is divided into five sections to cover the following items: 1. Use of antibiotics pattern 2. Knowledge about antibiotics 3. Sources of information |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Group of pediatric dentists
Key inclusion criteria (1 listed)
- Dentists of pediatric dentistry working for children aged. Dentists who have BDS degree in the last 20 years.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pattern of antibiotic prescription in children
Time frame: baseline
Questionnaire (Kaul et al., 2018), Multiple choice question
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Results publication: PubMed 29991865Kaul R, Angrish P, Jain P, Saha S, V Sengupta A, Mukherjee S. A Survey on the Use of Antibiotics among the Dentists of Kolkata, West Bengal, India. Int J Clin Pediatr Dent. 2018 Mar-Apr;11(2):122-127. doi: 10.5005/jp-journals-10005-1497. Epub 2018 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed M EL-Gendy, BDS principal investigator
Dentist at Ministry of Health,EGYPT
Fatma Kl EL-Gendy, PhD study chair
Assistant Professor at Pediatric Dentistry and Dental Public Health Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Strain, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 ahmed M EL-Gendy, BDS (00201092524899, ahmed_abdo@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of antibiotic prescription in children (time frame: baseline). 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 NCT04795518, which also lists 1 linked publication.
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 Mar 2021.