Clarithromycin as Adjuvant to Periodontal Debridement

• ClinicalTrials.gov Identifier: NCT02829983
• Recruitment Status: Completed
• First Posted: July 12, 2016
• Results First Posted: October 17, 2017
• Last Update Posted: November 21, 2017
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Collaborator: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Information provided by (Responsible Party): Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Tracking Information

• First Submitted Date: July 8, 2016
• First Posted Date: July 12, 2016
• Results First Submitted Date: May 9, 2017
• Results First Posted Date: October 17, 2017
• Last Update Posted Date: November 21, 2017
• Study Start Date: March 2014
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2017)

Clinical Attachment Level [ Time Frame: 6 months ]

Distance from bottom of pocket to the cement-enamel junction (CEJ).

• Original Primary Outcome Measures (submitted: July 8, 2016): Clinical Attachment Level [ Time Frame: 6 months ]

Current Secondary Outcome Measures (submitted: October 16, 2017)

Probing Depth [ Time Frame: 6 months ]

Distance from the bottom of sulcus/pocket to gingival margin

• Original Secondary Outcome Measures (submitted: July 8, 2016): Probing Depth [ Time Frame: 6 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clarithromycin as Adjuvant to Periodontal Debridement
• Official Title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Aggressive Periodontitis

Intervention

• Drug: Clarithromycin
  Use of 500mg of Clarithromycin twice a day for 3 days
  Other Name: macrolide
• Drug: 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.

Study Arms

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

  • Drug: Clarithromycin
  • Other: One-stage full-mouth ultrasonic debridement (FMUD)
• Placebo Comparator: placebo group
  20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
  Interventions:

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

Publications *

• 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 treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.
• 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:CD012568. doi: 10.1002/14651858.CD012568.pub2.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2016): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02829983
• Other Study ID Numbers: NMRBA
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Undecided

• Responsible Party: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
• Study Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

• Study Director: Mauro P Santamaria, DDS, PhD; UPECLIN HC FM Botucatu Unesp

• PRS Account: Universidade Estadual Paulista Júlio de Mesquita Filho
• Verification Date: October 2017