Aggressive Periodontitis
Conditions
Keywords
clarithromycin, periodontal debridement, aggressive periodontitis
Brief summary
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.
Detailed description
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.
Interventions
DRUGClarithromycin
Use of 500mg of Clarithromycin twice a day for 3 days
DRUGPlacebo
Use of placebo tablets twice a day for 3 days.
OTHEROne-stage full-mouth ultrasonic debridement (FMUD)
One session of Periodontal debridement using ultrasonic device.
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of Generalized Aggressive Periodontitis * presence of ≥20 teeth * presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites 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 * agree to participate in the study and sign a written consent
Exclusion criteria
* pregnant or lactating * suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease * received antimicrobials in the previous 6 months * taking long-term anti-inflammatory drugs * received a course of periodontal treatment within the last 12 months * smoked
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level | 6 months | Distance from bottom of pocket to the cement-enamel junction (CEJ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth | 6 months | Distance from the bottom of sulcus/pocket to gingival margin |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Clarithromycin Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 3.7 | 31.25 years STANDARD_DEVIATION 4.6 | 31.32 years STANDARD_DEVIATION 0.1 |
| bleeding on probing | 53 percentage of sites STANDARD_DEVIATION 19 | 54 percentage of sites STANDARD_DEVIATION 30 | 53.5 percentage of sites STANDARD_DEVIATION 0.7 |
| clinical attachment level | 3.48 milimeter STANDARD_DEVIATION 0.66 | 3.63 milimeter STANDARD_DEVIATION 0.7 | 3.55 milimeter STANDARD_DEVIATION 0.1 |
| gingival recession | 0.14 milimeter STANDARD_DEVIATION 0.16 | 0.1 milimeter STANDARD_DEVIATION 0.12 | 0.12 milimeter STANDARD_DEVIATION 0.028 |
| plaque index | 59 percentage of sites STANDARD_DEVIATION 23 | 62 percentage of sites STANDARD_DEVIATION 25 | 60.5 percentage of sites STANDARD_DEVIATION 2.12 |
| Probing depht | 3.34 milimeter STANDARD_DEVIATION 0.56 | 3.53 milimeter STANDARD_DEVIATION 0.6 | 3.43 milimeter STANDARD_DEVIATION 0.13 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Clinical Attachment Level
Distance from bottom of pocket to the cement-enamel junction (CEJ).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clarithromycin Group | Clinical Attachment Level | 2.71 milimeter | Standard Deviation 0.35 |
| Placebo Group | Clinical Attachment Level | 3.03 milimeter | Standard Deviation 0.55 |
Secondary
Probing Depth
Distance from the bottom of sulcus/pocket to gingival margin
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clarithromycin Group | Probing Depth | 2.53 milimeter | Standard Deviation 0.3 |
| Placebo Group | Probing Depth | 2.86 milimeter | Standard Deviation 0.52 |