Amoxicillin and Metronidazole During Periodontal Treatment (MOMENT)

Belén Retamal-Valdes

Status: Unknown

Conditions: Chronic Periodontitis

Treatments: Drug: Metronidazole active phase; Drug: Placebos active phase; Drug: Amoxicillin active phase; Drug: Metronidazole healing phase; Drug: Amoxicillin healing phase; Procedure: Scaling and root planing; Drug: Placebos healing phase

Study type: Interventional

Funder types: Other

Identifiers

NCT02954393

CAAE: 32465714.4.1001.5506

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 180 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

180 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.

Treatment:

Drug: Placebos healing phase

Procedure: Scaling and root planing

Drug: Placebos active phase

Active phase

Active Comparator group

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.

Treatment:

Drug: Placebos healing phase

Procedure: Scaling and root planing

Drug: Amoxicillin active phase

Drug: Metronidazole active phase

Healing phase

Active Comparator group

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.

Treatment:

Drug: Amoxicillin healing phase

Procedure: Scaling and root planing

Drug: Metronidazole healing phase

Drug: Placebos active phase