Back to resultsAmoxicillin and Metronidazole During Periodontal Treatment (MOMENT)
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scaling and root planing
Metronidazole active phase
Metronidazole healing phase
Amoxicillin active phase
Amoxicillin healing phase
Placebos active phase
Placebos healing phase
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontal disease, Metronidazole, Amoxicillin, Scaling and root planing, Healing phase
Eligibility Criteria
Inclusion Criteria:
- ≥35 years of age;
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
- at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- current smoking and former smoking within the past 5 years;
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- scaling and root planing an in the previous 6 months;
- antibiotic therapy in the previous 6 months;
- long-term intake of anti-inflammatory medications;
- need for antibiotic pre-medication for routine dental therapy;
- use of orthodontic appliances;
- extensive dental prosthetic rehabilitation;
- allergy to metronidazole and/or amoxicillin.
Sites / Locations
- University of Guarulhos
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control
Active phase
Healing phase
Arm Description
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
Outcomes
Primary Outcome Measures
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Secondary Outcome Measures
Number of sites with PD ≥ 5 mm.
Number of sites with PD ≥ 6 mm.
Number of sites with PD ≥ 7 mm.
Reduction in the number of sites with PD ≥ 5 mm.
Reduction in the number of sites with PD ≥ 6 mm.
Reduction in the number of sites with PD ≥ 7 mm.
Mean PD changes in sites with initial PD between 4-6 mm
Mean PD changes in sites with initial PD ≥ 7 mm.
Mean CAL changes in sites with initial CAL between 4-6 mm
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Full-mouth PD.
Full-mouth clinical attachment level.
Percentage of sites with bleeding on probing.
Percentage of sites with plaque accumulation
Percentage of sites with marginal bleeding.
Occurrence of headache obtained through a questionnaire of adverse effects.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Proportions of periodontal pathogenic bacterial species.
Counts of periodontal pathogenic bacterial species.
Counts of chemokines in the crevicular gingival fluid.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02954393
Brief Title
Amoxicillin and Metronidazole During Periodontal Treatment
Acronym
MOMENT
Official Title
Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Belén Retamal-Valdes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.
Detailed Description
The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) to scaling and root planing (SRP) has shown to be a promising periodontal treatment. However, some essential issues associated with the use of these antibiotics remain to be established. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this multicentric RCT is to compare the clinical, microbiological and immunological effects of adjunctive systemic MTZ+AMX administered in different phases of the treatment of generalized chronic periodontitis (GChP). 180 subjects with GChP will be randomly assigned into three groups (n=60/group) that will receive SRP-only (control group) or in combination with 400 mg MTZ+500 mg AMX beginning at the first SRP session (group test 1) or after 3 months of its completion (group test 2). All volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. Nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Periodontal disease, Metronidazole, Amoxicillin, Scaling and root planing, Healing phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
Arm Title
Active phase
Arm Type
Active Comparator
Arm Description
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
Arm Title
Healing phase
Arm Type
Active Comparator
Arm Description
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
SRP
Intervention Description
SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
Intervention Type
Drug
Intervention Name(s)
Metronidazole active phase
Other Intervention Name(s)
MTZ 1
Intervention Description
Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Intervention Type
Drug
Intervention Name(s)
Metronidazole healing phase
Other Intervention Name(s)
MTZ 2
Intervention Description
Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Intervention Type
Drug
Intervention Name(s)
Amoxicillin active phase
Other Intervention Name(s)
AMX 1
Intervention Description
Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Intervention Type
Drug
Intervention Name(s)
Amoxicillin healing phase
Other Intervention Name(s)
AMX 2
Intervention Description
Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Intervention Type
Drug
Intervention Name(s)
Placebos active phase
Other Intervention Name(s)
P 1
Intervention Description
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Intervention Type
Drug
Intervention Name(s)
Placebos healing phase
Other Intervention Name(s)
P 2
Intervention Description
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
Primary Outcome Measure Information:
Title
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of sites with PD ≥ 5 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Number of sites with PD ≥ 6 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Number of sites with PD ≥ 7 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Reduction in the number of sites with PD ≥ 5 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Reduction in the number of sites with PD ≥ 6 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Reduction in the number of sites with PD ≥ 7 mm.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Mean PD changes in sites with initial PD between 4-6 mm
Time Frame
Baseline - 12 months.
Title
Mean PD changes in sites with initial PD ≥ 7 mm.
Time Frame
Baseline - 12 months.
Title
Mean CAL changes in sites with initial CAL between 4-6 mm
Time Frame
Baseline - 12 months.
Title
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Time Frame
Baseline - 12 months.
Title
Full-mouth PD.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Full-mouth clinical attachment level.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Percentage of sites with bleeding on probing.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Percentage of sites with plaque accumulation
Time Frame
Baseline, 3, 6 and 12 months.
Title
Percentage of sites with marginal bleeding.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Occurrence of headache obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Occurrence of irritability obtained through a questionnaire of adverse effects.
Time Frame
14 days after taking antibiotic.
Title
Proportions of periodontal pathogenic bacterial species.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Counts of periodontal pathogenic bacterial species.
Time Frame
Baseline, 3, 6 and 12 months.
Title
Counts of chemokines in the crevicular gingival fluid.
Time Frame
Baseline and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥35 years of age;
at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
Exclusion Criteria:
pregnancy;
breastfeeding;
current smoking and former smoking within the past 5 years;
systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
scaling and root planing an in the previous 6 months;
antibiotic therapy in the previous 6 months;
long-term intake of anti-inflammatory medications;
need for antibiotic pre-medication for routine dental therapy;
use of orthodontic appliances;
extensive dental prosthetic rehabilitation;
allergy to metronidazole and/or amoxicillin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Feres, Professor
Organizational Affiliation
University of Guarulhos
Official's Role
Study Chair
Facility Information:
Facility Name
University of Guarulhos
City
Guarulhos
State/Province
São Paulo
ZIP/Postal Code
07023-070
Country
Brazil
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Amoxicillin and Metronidazole During Periodontal Treatment
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