Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis. (Metro + Amoxi)
Primary Purpose
Chronic Periodontitis, Clinical and Microbiological Effects
Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Administration of Metronidazole plus Amoxicillin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic periodontitis, Metronidazole plus Amoxicillin, Mechanical periodontal therapy, Scaling and Root Planning, Periodontal treatment
Eligibility Criteria
Inclusion Criteria:
- a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one site in three of the four quadrants with clinical attachment loss ≥ 3mm; d) at least 4 sites in different teeth with probing depth and clinical attachment level ≥ 6mm and bleeding on probing and at least 14 tooth present in the mouth
Exclusion Criteria:
- a) previous professional root planning; b) systemic/topic antibiotic or antiinflammatory treatment, at least 6 months prior to the initiation of the study; c) immunosuppression or need for antibiotic coverage for routine dental therapy; d) systemic condition that could affect the progression of periodontal disease (diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or amoxicillin; f) smokers
Sites / Locations
- Facultad de Odontologia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Scaling and root planning + placebo + antibiotics
Arm Description
Scaling and root planning + placebo Scaling and root planning + metronidazole plus amoxicillin Metronidazole plus amoxicillin + scaling and root planning
Outcomes
Primary Outcome Measures
- Mean change in clinical attachment level (CAL)
Secondary Outcome Measures
- Mean change in probing pocket depths (PD)
Full Information
NCT ID
NCT01211223
First Posted
September 28, 2010
Last Updated
June 15, 2016
Sponsor
University of Chile
Collaborators
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT01211223
Brief Title
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Acronym
Metro + Amoxi
Official Title
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
• Background: Peridontitis is a group of diseases with complex bacterial etiology that affects a large proportion of the Chilean and worldwide population. Its treatment, based on an anti-infective mechanical therapy including scaling and root planning procedures, has been highly effective in numerous short and long term clinical trials. The use of adjunctive systemic antibiotics has shown significant improvements in the initial therapy results of specific periodontal disease types or patient profiles.
The synergic combination of Metronidazole plus amoxicillin has been widely and successfully used for the treatment of aggressive and severe chronic periodontitis, demonstrating additional benefits in clinical and microbiological parameters over scaling and root planning alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates the impact of antimicrobials intake at different times of the mechanical treatment, emphasizing the necessity of a study that compares, simultaneously, the variation of the adjunctive antibiotic effects when they are administered in different moments through the periodontal therapy course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Clinical and Microbiological Effects
Keywords
Chronic periodontitis, Metronidazole plus Amoxicillin, Mechanical periodontal therapy, Scaling and Root Planning, Periodontal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scaling and root planning + placebo + antibiotics
Arm Type
Experimental
Arm Description
Scaling and root planning + placebo
Scaling and root planning + metronidazole plus amoxicillin
Metronidazole plus amoxicillin + scaling and root planning
Intervention Type
Drug
Intervention Name(s)
Administration of Metronidazole plus Amoxicillin
Intervention Description
Metronidazole plus Amoxicillin after, during and after root planning
Primary Outcome Measure Information:
Title
- Mean change in clinical attachment level (CAL)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
- Mean change in probing pocket depths (PD)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one site in three of the four quadrants with clinical attachment loss ≥ 3mm; d) at least 4 sites in different teeth with probing depth and clinical attachment level ≥ 6mm and bleeding on probing and at least 14 tooth present in the mouth
Exclusion Criteria:
a) previous professional root planning; b) systemic/topic antibiotic or antiinflammatory treatment, at least 6 months prior to the initiation of the study; c) immunosuppression or need for antibiotic coverage for routine dental therapy; d) systemic condition that could affect the progression of periodontal disease (diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or amoxicillin; f) smokers
Facility Information:
Facility Name
Facultad de Odontologia
City
Santiago
State/Province
R Metropolitana
ZIP/Postal Code
Santiago
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
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