Clinical trial NCT02829983: Clarithromycin as Adjuvant to Periodontal Debridement
Official title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggressive Periodontitis
Keywords: clarithromycin
periodontal debridement
aggressive periodontitis
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 6 months
Secondary outcomes:
measure: Probing Depth
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Mauro P Santamaria, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.