Clarithromycin as Adjuvant to Periodontal Debridement

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Completed

Conditions: Aggressive Periodontitis

Treatments: Drug: Clarithromycin; Other: One-stage full-mouth ultrasonic debridement (FMUD); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02829983

NMRBA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

clarithromycin group

Active Comparator group

Description:

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.

Treatment:

Drug: Clarithromycin

Other: One-stage full-mouth ultrasonic debridement (FMUD)

placebo group

Placebo Comparator group

Description:

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Treatment:

Drug: Placebo

Other: One-stage full-mouth ultrasonic debridement (FMUD)