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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clarithromycin group | Active Comparator | 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. |
|
| placebo group | Placebo Comparator | 20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin | Drug | Use of 500mg of Clarithromycin twice a day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level | Distance from bottom of pocket to the cement-enamel junction (CEJ). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | Distance from the bottom of sulcus/pocket to gingival margin | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro P Santamaria, DDS, PhD | UPECLIN HC FM Botucatu Unesp | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22288485 | Result | Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Goncalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30. | |
| 34790237 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clarithromycin Group | 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. |
| FG001 | Placebo Group | 20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clarithromycin Group | 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Attachment Level | Distance from bottom of pocket to the cement-enamel junction (CEJ). | Posted | Mean | Standard Deviation | milimeter | 6 months |
|
1 week after periodontal treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clarithromycin Group | 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mauro Pedrine Santamaria | Universidade Estadual Paulista Júlio de Mesquita Filho | 3947-9033 | mauro.santamaria@ict.unesp.br |
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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 |
|---|---|
| D017291 | Clarithromycin |
| D018942 | Macrolides |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Use of placebo tablets twice a day for 3 days. |
|
| One-stage full-mouth ultrasonic debridement (FMUD) | Other | One session of Periodontal debridement using ultrasonic device. |
|
| Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021. |
| 33197289 | Derived | Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2. |
| 28671507 | Derived | Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3. |
| BG001 |
| Placebo Group |
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Probing depht | Mean | Standard Deviation | milimeter |
|
| clinical attachment level | Mean | Standard Deviation | milimeter |
|
| bleeding on probing | Mean | Standard Deviation | percentage of sites |
|
| gingival recession | Mean | Standard Deviation | milimeter |
|
| plaque index | Plaque index is the relation between the sites with deposits of plaque and the sites of full mouth divided for 100. | Mean | Standard Deviation | percentage of sites |
|
|
|
| Secondary | Probing Depth | Distance from the bottom of sulcus/pocket to gingival margin | Posted | Mean | Standard Deviation | milimeter | 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Placebo Group | 20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D047028 |
| Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |