Clarithromycin as Adjuvant to Periodontal Debridement

Aggressive Periodontitis Clinical Trial

Official title:

Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829983
• Other study ID #: NMRBA
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: October 18, 2017
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2017
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis

Intervention

Drug:
• Clarithromycin
Use of 500mg of Clarithromycin twice a day for 3 days
• Placebo
Use of placebo tablets twice a day for 3 days.

Other:
• One-stage full-mouth ultrasonic debridement (FMUD)
One session of Periodontal debridement using ultrasonic device.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

References & Publications (1)

Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Gonçalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis trea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	Distance from bottom of pocket to the cement-enamel junction (CEJ).	6 months
Secondary	Probing Depth	Distance from the bottom of sulcus/pocket to gingival margin	6 months