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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)

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ClinicalTrials.gov Identifier: NCT01211223
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Jorge Gamonal, University of Chile

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Clinical and Microbiological Effects Drug: Administration of Metronidazole plus Amoxicillin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2014


Arm Intervention/treatment
Experimental: Scaling and root planning + placebo + antibiotics
  • Scaling and root planning + placebo
  • Scaling and root planning + metronidazole plus amoxicillin
  • Metronidazole plus amoxicillin + scaling and root planning
Drug: Administration of Metronidazole plus Amoxicillin
Metronidazole plus Amoxicillin after, during and after root planning




Primary Outcome Measures :
  1. - Mean change in clinical attachment level (CAL) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. - Mean change in probing pocket depths (PD) [ Time Frame: 12 months ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211223


Locations
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Chile
Facultad de Odontologia
Santiago, R Metropolitana, Chile, Santiago
Sponsors and Collaborators
University of Chile
Colgate Palmolive

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Responsible Party: Jorge Gamonal, Academic, University of Chile
ClinicalTrials.gov Identifier: NCT01211223     History of Changes
Other Study ID Numbers: Facultad Odontologia, U Chile
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Keywords provided by Jorge Gamonal, University of Chile:
Chronic periodontitis
Metronidazole plus Amoxicillin
Mechanical periodontal therapy
Scaling and Root Planning
Periodontal treatment
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents