Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
Primary Purpose
Aggressive Periodontitis
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Full-mouth ultrasonic debridement
Clarithromycin
Amoxicillin
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Full-mouth ultrasonic debridement, Clarithromycin, Amoxicillin, Metronidazole
Eligibility Criteria
Inclusion Criteria:
- diagnosis of GAgP (AAP, 1999);
- presence of ≥20 teeth;
- presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
- good general health;
- ≤ 35 years old; and
- agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).
Exclusion Criteria:
- pregnancy or lactating;
- suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
- took antimicrobials in the previous 6 months;
- taking long-term anti-inflammatory drugs;
- previous periodontal treatment within the last 12 months;
- smokers.
Sites / Locations
- College of Dentistry - São José dos Campos, Sao Paulo State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Amoxicillin and Metronidazole
Clarithromycin
Arm Description
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Outcomes
Primary Outcome Measures
Change in Clinical Attachment Level (CAL)
Evaluate the difference between baseline and 6 months CAL measures.
Secondary Outcome Measures
Change in Probing Depth (PB)
Evaluate the difference between baseline and 6 months PB measures.
Change in Bleeding on Probe (BoP)
Evaluate the difference between baseline and 6 months BoP measures.
Full Information
NCT ID
NCT02969928
First Posted
November 7, 2016
Last Updated
December 23, 2021
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT02969928
Brief Title
Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
Official Title
Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).
Detailed Description
The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled clinical trials.
Study Design
The study is designed as a prospective, interventional, parallel, triple blind, randomized, controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol 1.079.307).
Source of data
The population of this study will be recruited among patients referred to the Science and Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, 44 subjects divided into two groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical attachment level (CAL) of patients.
Clinical Parameters
All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars.
The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2) Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.
Calibration and Randomization
Initially, a total of ten patients presenting with GAgP will be selected. The designated examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an interval of ≥ 1 hour between examinations. Then, the measures will be submitted to intraclass correlation test and the examiner will be judged calibrated if reaches 90% agreement.
Patients will be allocated into two groups according to a computer-generated list. The allocation will be implemented by an investigator (NCCS) who was not directly involved in the examination or treatment procedures. All medication will be prepared and encased in identical opaque coded bottles by a manipulation pharmacy on São José dos Campos/São Paulo.
Treatment Protocols
All patients will be treated with periodontal therapy through of the one-stage, full mouth, ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this one session. The debridement session will be performed by a single experienced and trained periodontist (MPS), different from the examiner. Immediately before the mechanical therapy, patients will be allocated in one of the two treatment protocols:
Clarithromycin (CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days and
Amoxicillin (AMX) + metronidazole (MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400 mg tid, both for 7 days.
All patients will start taking the pills immediately before of the FMUD session.
Compliance and Adverse Effects
After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented. Moreover, patients will be instructed to return a self-report form filled about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.
Statistical analysis
Mean and standard deviation will be calculated for each parameter. The normal distribution of the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be subjected to analysis of variance (repeated measures) for inter and intra-group comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
Full-mouth ultrasonic debridement, Clarithromycin, Amoxicillin, Metronidazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin and Metronidazole
Arm Type
Active Comparator
Arm Description
In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Arm Title
Clarithromycin
Arm Type
Experimental
Arm Description
In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Intervention Type
Procedure
Intervention Name(s)
Full-mouth ultrasonic debridement
Other Intervention Name(s)
Periodontal debridement
Intervention Description
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
Biaxin
Intervention Description
Administration of Clarithromycin 500mg bid for 7 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxil
Intervention Description
Administration of Amoxicillin 500mg tid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
Administration of Metronidazole 400mg tid for 7 days.
Primary Outcome Measure Information:
Title
Change in Clinical Attachment Level (CAL)
Description
Evaluate the difference between baseline and 6 months CAL measures.
Time Frame
Baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in Probing Depth (PB)
Description
Evaluate the difference between baseline and 6 months PB measures.
Time Frame
Baseline, 3 and 6 months
Title
Change in Bleeding on Probe (BoP)
Description
Evaluate the difference between baseline and 6 months BoP measures.
Time Frame
Baseline, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Compliance
Description
After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.
Time Frame
One week post treatment
Title
Adverse Effects That May be Related to Antibiotic Treatment
Description
Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.
Time Frame
One week post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of GAgP (AAP, 1999);
presence of ≥20 teeth;
presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
good general health;
≤ 35 years old; and
agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).
Exclusion Criteria:
pregnancy or lactating;
suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
took antimicrobials in the previous 6 months;
taking long-term anti-inflammatory drugs;
previous periodontal treatment within the last 12 months;
smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
Universidade Estadual Paulista Júlio de Mesquita Filho
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry - São José dos Campos, Sao Paulo State University
City
São José dos Campos
State/Province
SP
ZIP/Postal Code
12245-310
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21529775
Citation
Pradeep AR, Kathariya R. Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. Arch Oral Biol. 2011 Oct;56(10):1112-9. doi: 10.1016/j.archoralbio.2011.03.021. Epub 2011 May 6.
Results Reference
background
PubMed Identifier
20447259
Citation
Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.
Results Reference
background
PubMed Identifier
33197289
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.
Results Reference
derived
PubMed Identifier
31257591
Citation
Araujo CF, Andere NMRB, Castro Dos Santos NC, Mathias-Santamaria IF, Reis AA, de Oliveira LD, Jardini MAN, Casarin RCV, Santamaria MP. Two different antibiotic protocols as adjuncts to one-stage full-mouth ultrasonic debridement to treat generalized aggressive periodontitis: A pilot randomized controlled clinical trial. J Periodontol. 2019 Dec;90(12):1431-1440. doi: 10.1002/JPER.18-0399. Epub 2019 Jul 16.
Results Reference
derived
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Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
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