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Completed

NCT Number: NCT03933501

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

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).

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Key information

Conditions

Generalized Aggressive Periodontitis Aggressive Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin and Metronidazole

Drug

375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.

Placebos

Drug

Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2018
First posted
May 1, 2019
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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