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

• ClinicalTrials.gov Identifier: NCT03933501
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: May 13, 2019
• Sponsor: University of Campinas, Brazil
• Information provided by (Responsible Party): Renato Casarin, University of Campinas, Brazil

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Generalized Aggressive Periodontitis	Drug: amoxicillin and metronidazole; Drug: Placebos	Phase 4

Detailed 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%).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
• Actual Study Start Date: January 1, 2006
• Actual Primary Completion Date: December 1, 2008
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: FMUD + AM; One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.	Drug: amoxicillin and metronidazole; 375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
Placebo Comparator: FMUD; One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.	Drug: Placebos; Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
Experimental: SRP + AM; Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.	Drug: amoxicillin and metronidazole; 375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
Placebo Comparator: SRP; Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.	Drug: Placebos; Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Outcome Measures

Primary Outcome Measures :

1. Change of the baseline relative clinical attachment level at 6 months [ Time Frame: Baseline, 3 months and 6 months ]
   distance from the bottom of the pocket to the stent margin.

Secondary Outcome Measures :

1. Change of the baseline probing depth at 6 months [ Time Frame: Baseline, 3 months and 6 months ]
   Distance from the bottom of pocket to gingival margin;
2. Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months [ Time Frame: Baseline, 3 months and 6 months ]
   Concentration of IL-1β, IL-10 released in gingival crevicular fluid
3. Change in the microbial composition at 6 months [ Time Frame: Baseline, 3 months and 6 months ]
   Concentration of bacteria in the subgingival biofilm

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.

• Responsible Party: Renato Casarin, Professor at Piracicaba Dental School, University of Campinas, Brazil
• ClinicalTrials.gov Identifier: NCT03933501
• Other Study ID Numbers: 06/0024
• First Posted: May 1, 2019
• Last Update Posted: May 13, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Renato Casarin, University of Campinas, Brazil:

Aggressive periodontitis; anti-infective agents; debridement; randomized clinical trial; ultrasonic

Additional relevant MeSH terms:

Periodontitis; Aggressive Periodontitis; Aggression; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavioral Symptoms; Amoxicillin; Metronidazole; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents