Clarithromycin as Adjuvant to Periodontal Debridement
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedResults Posted
Study results publicly available
October 17, 2017
CompletedNovember 21, 2017
October 1, 2017
1.4 years
July 8, 2016
May 9, 2017
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
Distance from bottom of pocket to the cement-enamel junction (CEJ).
6 months
Secondary Outcomes (1)
Probing Depth
6 months
Study Arms (2)
clarithromycin group
ACTIVE COMPARATOR20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
placebo group
PLACEBO COMPARATOR20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Interventions
Use of 500mg of Clarithromycin twice a day for 3 days
One session of Periodontal debridement using ultrasonic device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 22288485RESULTHammami 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.
PMID: 34790237DERIVEDKhattri 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.
PMID: 33197289DERIVEDAndere 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.
PMID: 28671507DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mauro Pedrine Santamaria
- Organization
- Universidade Estadual Paulista Júlio de Mesquita Filho
Study Officials
- STUDY DIRECTOR
Mauro P Santamaria, DDS, PhD
UPECLIN HC FM Botucatu Unesp
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS,MS,PhD
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 12, 2016
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
November 21, 2017
Results First Posted
October 17, 2017
Record last verified: 2017-10