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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMUD + AM | Experimental | 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. |
|
| FMUD | Placebo Comparator | 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. |
|
| SRP + AM | Experimental | 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. |
|
| SRP | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amoxicillin and metronidazole | Drug | 375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31448837 | Derived | 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. |
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| ID | Term |
|---|---|
| D010520 | Aggressive Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Placebos | Drug | Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days. |
|
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 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |