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

Study Overview
=================
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).

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%).

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

Conditions
-----------------
Generalized Aggressive Periodontitis

Intervention / Treatment
-----------------
* Drug: amoxicillin and metronidazole
* Drug: Placebos


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMUD + AM<br>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<br>* 375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.<br>|
| Placebo Comparator: FMUD<br>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<br>* Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.<br>|
| Experimental: SRP + AM<br>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<br>* 375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.<br>|
| Placebo Comparator: SRP<br>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<br>* Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aggressive periodontitis, anti-infective agents, debridement, randomized clinical trial, ultrasonic