Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

Generalized Aggressive Periodontitis Clinical Trial

Official title:

The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933501
• Other study ID #: 06/0024
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2006
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2019
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).

Description:

Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of GAgP;

• presence of 20 teeth;

• presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth with PD>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);

• good general health;

• <35 years of age.

Exclusion Criteria:

• were pregnant or lactating;

• were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);

• received antimicrobials in the previous 3 months;

• were taking long-term anti-inflammatory drugs;

• received a course of periodontal treatment within the last 6 months;

• smoked

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Generalized Aggressive Periodontitis
• Periodontitis

Intervention

Drug:
• amoxicillin and metronidazole
375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
• Placebos
Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the baseline relative clinical attachment level at 6 months	distance from the bottom of the pocket to the stent margin.	Baseline, 3 months and 6 months
Secondary	Change of the baseline probing depth at 6 months	Distance from the bottom of pocket to gingival margin;	Baseline, 3 months and 6 months
Secondary	Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months	Concentration of IL-1ß, IL-10 released in gingival crevicular fluid	Baseline, 3 months and 6 months
Secondary	Change in the microbial composition at 6 months	Concentration of bacteria in the subgingival biofilm	Baseline, 3 months and 6 months