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

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

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%).

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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


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.




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



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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

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

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