NCT06177119

Amoxicillin and Metronidazole During or After the Periodontal Treatment

Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis: Clinical and Microbiological Evaluation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Belén Retamal-Valdes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Scaling and root planing	SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
DRUG	Placebos during SRP	Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session.
DRUG	Placebos after SRP	Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session.
DRUG	Metronidazole during SRP	Metronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session.
DRUG	Amoxicillin during SRP	Amoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session.
DRUG	Metronidazole after SRP	Metronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session.
DRUG	Amoxicillin after SRP	Amoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session.

Timeline

• Start date: 2012-01-31
• Primary completion: 2012-07-01
• Completion: 2024-12-31
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: Brazil