Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502288
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Evaluation of Antibiotic Administration Following Tooth Extraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Necessity of Antibiotic Administration Following Tooth Extraction A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial aims to evaluate the effects of prescribing antibiotics after tooth extraction 152 dental patients aged 18 to 50 will be randomly assigned The study will assess infection rates healing times pain and adverse effects in patients who receive antibiotics versus those who do not The trial will be conducted at the Oral and Maxillofacial Surgery Department Dental Unit Chittagong Medical College Data analysis will involve the use of the χ²-test t-tests and logistic regression with a significance level of 5 Ethical considerations include obtaining informed consent from all participants and safety will be monitored by an independent expert team
Detailed Description:
Antibiotics are commonly prescribed in dentistry as a prophylactic measure particularly following tooth extraction which are overused and misused in dental practice leading to a rise in antimicrobial resistance By randomly assigning 152 dental patients aged between 18 to 50 years this trial aims to evaluate the outcomes such as infection rates healing times pain and adverse effects of patients receiving antibiotics after tooth extraction versus those who do not The study will be conducted at the Oral and Maxillofacial Surgery Department Dental Unit Chittagong Medical College
Tooth extractions will be performed under aseptic conditions followed by standard post-operative care The intervention group will receive 625 mg amoxicillin with clavulanic acid three times daily for 7 days post-extraction while the control group will not receive any antibiotic Both groups will receive 400 mg ibuprofen and 20 mg omeprazole twice daily Surgeons patients and assessors will be blinded to group assignments with a third party managing medication distribution Clinical evaluations will occur on the 3rd 7th and 14th days post-extraction The Landry wound healing index will be used to assess tissue healing and pain will be recorded using a visual analogue scale Surgical Site Infection will be diagnosed based on specific clinical criteria Any Adverse reactions will be monitored Rescue Additional analgesia and antibiotics will be provided as needed
Data analysis will be done using the χ²-test t-tests and logistic regression with a significance level of 5 Ethical considerations include obtaining informed consent from all participants An independent expert team will conduct safety monitoring to manage any adverse events The results of this study could provide valuable insights for future clinical protocols in dental surgery and contribute to the broader public health goal of reducing unnecessary antibiotic use
Tooth extractions will be performed under aseptic conditions followed by standard post-operative care The intervention group will receive 625 mg amoxicillin with clavulanic acid three times daily for 7 days post-extraction while the control group will not receive any antibiotic Both groups will receive 400 mg ibuprofen and 20 mg omeprazole twice daily Surgeons patients and assessors will be blinded to group assignments with a third party managing medication distribution Clinical evaluations will occur on the 3rd 7th and 14th days post-extraction The Landry wound healing index will be used to assess tissue healing and pain will be recorded using a visual analogue scale Surgical Site Infection will be diagnosed based on specific clinical criteria Any Adverse reactions will be monitored Rescue Additional analgesia and antibiotics will be provided as needed
Data analysis will be done using the χ²-test t-tests and logistic regression with a significance level of 5 Ethical considerations include obtaining informed consent from all participants An independent expert team will conduct safety monitoring to manage any adverse events The results of this study could provide valuable insights for future clinical protocols in dental surgery and contribute to the broader public health goal of reducing unnecessary antibiotic use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None