ClinicalTrials.gov
ClinicalTrials.gov Menu

Amoxicillin and Metronidazole During Periodontal Treatment (MOMENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02954393
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Belén Retamal-Valdes, University of Guarulhos

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Scaling and root planing Drug: Metronidazole active phase Drug: Metronidazole healing phase Drug: Amoxicillin active phase Drug: Amoxicillin healing phase Drug: Placebos active phase Drug: Placebos healing phase Not Applicable

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%.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
Study Start Date : May 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Placebo Comparator: Control
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
Procedure: Scaling and root planing
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.
Other Name: SRP

Drug: Placebos active phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Other Name: P 1

Drug: Placebos healing phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
Other Name: P 2

Active Comparator: Active phase
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.
Procedure: Scaling and root planing
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.
Other Name: SRP

Drug: Metronidazole active phase
Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Other Name: MTZ 1

Drug: Amoxicillin active phase
Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Other Name: AMX 1

Drug: Placebos healing phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
Other Name: P 2

Active Comparator: Healing phase
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.
Procedure: Scaling and root planing
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.
Other Name: SRP

Drug: Metronidazole healing phase
Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Other Name: MTZ 2

Drug: Amoxicillin healing phase
Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Other Name: AMX 2

Drug: Placebos active phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Other Name: P 1




Primary Outcome Measures :
  1. Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of sites with PD ≥ 5 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  2. Number of sites with PD ≥ 6 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  3. Number of sites with PD ≥ 7 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  4. Reduction in the number of sites with PD ≥ 5 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  5. Reduction in the number of sites with PD ≥ 6 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  6. Reduction in the number of sites with PD ≥ 7 mm. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  7. Mean PD changes in sites with initial PD between 4-6 mm [ Time Frame: Baseline - 12 months. ]
  8. Mean PD changes in sites with initial PD ≥ 7 mm. [ Time Frame: Baseline - 12 months. ]
  9. Mean CAL changes in sites with initial CAL between 4-6 mm [ Time Frame: Baseline - 12 months. ]
  10. Mean CAL changes in sites with initial CAL ≥ 7 mm. [ Time Frame: Baseline - 12 months. ]
  11. Full-mouth PD. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  12. Full-mouth clinical attachment level. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  13. Percentage of sites with bleeding on probing. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  14. Percentage of sites with plaque accumulation [ Time Frame: Baseline, 3, 6 and 12 months. ]
  15. Percentage of sites with marginal bleeding. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  16. Occurrence of headache obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  17. Occurrence of vomiting obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  18. Occurrence of diarrhea obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  19. Occurrence of metallic taste obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  20. Occurrence of nausea obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  21. Occurrence of irritability obtained through a questionnaire of adverse effects. [ Time Frame: 14 days after taking antibiotic. ]
  22. Proportions of periodontal pathogenic bacterial species. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  23. Counts of periodontal pathogenic bacterial species. [ Time Frame: Baseline, 3, 6 and 12 months. ]
  24. Counts of chemokines in the crevicular gingival fluid. [ Time Frame: Baseline and 12 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02954393


Contacts
Contact: Belen Retamal-Valdés, PhD student +55 (11) 942801064 belenretamalvaldes@gmail.com

Locations
Brazil
University of Guarulhos Recruiting
Guarulhos, São Paulo, Brazil, 07023-070
Contact: Belén Retamal-Valdes, PhD student    +55 11 942801064    belenretamalvaldes@gmail.com   
Contact: Samantha Carvalho    2464-1700 ext 1470071    scarvalho@ung.br   
Principal Investigator: Magda Feres, Professor         
Sub-Investigator: Marcelo Faveri, Professor         
Sub-Investigator: Luciene Figueiredo, Professor         
Sub-Investigator: Poliana Duarte, Professor         
Sub-Investigator: Maria Josefa Mestnik, Professor         
University of São Paulo Recruiting
São Paulo, Brazil, 05508-000
Contact: Maria Luisa Souto, PhD student    +55 11 30917833    mluisasouto@gmail.com   
Contact: Michelle Rodrigues, Master    +55 11 30917833    michelledfr@gmail.com   
Principal Investigator: Cláudio Pannuti, Professor         
Sub-Investigator: Giuseppe Romito, Professor         
Sub-Investigator: Luciana Saraiva, Professor         
Sponsors and Collaborators
Belén Retamal-Valdes
Investigators
Study Chair: Magda Feres, Professor University of Guarulhos

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Belén Retamal-Valdes, DDS, MSc, PhD Student, University of Guarulhos
ClinicalTrials.gov Identifier: NCT02954393     History of Changes
Other Study ID Numbers: CAAE: 32465714.4.1001.5506
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Belén Retamal-Valdes, University of Guarulhos:
Periodontal disease
Metronidazole
Amoxicillin
Scaling and root planing
Healing phase

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents