Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177119
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Amoxicillin and Metronidazole During or After the Periodontal Treatment
Sponsor:
Belén Retamal-Valdes
Organization:
University of Guarulhos
Study Overview
Official Title:
Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis Clinical and Microbiological Evaluation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole MTZ and amoxicillin AMX in the treatment of periodontitis
Detailed Description:
Scaling and root planing SRP is the most used periodontal therapy for periodontal treatment Despite leading in most cases to an improvement in periodontal clinical parameters SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health especially in cases of more advanced and generalized diseases Thus other therapies supporting SRP such as systemic antibiotics have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics especially the association of metronidazole MTZ and amoxicillin AMX in the treatment of severe periodontitis However some essential issues associated with the use of these antibiotics remain to be established Therefore the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole MTZ and amoxicillin AMX in the treatment of periodontitis Seventy-two subjects with severe periodontitis were selected and randomized into two groups n 36 group - Test 1 T1 SRP in 14 days associated with the concomitant use of AMX 500mg 3x day and MTZ 400mg 3x day for 14 days and Test 2 T2 SRP in 14 days associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days All volunteers received clinical and microbiological evaluation at baseline 3 6 and 12 months post-SRP Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA ANCOVA Chi-square and Tukey tests Microbiological analyzes were performed using adjustments for multiple comparisons Statistical significance was set at 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None