MTZ Plus AMX in the Treatment of Smokers and Non-smokers
Information source: University of Guarulhos
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Periodontitis; Smoking
Intervention: Metronidazole plus Amoxicillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Guarulhos Official(s) and/or principal investigator(s): Marcelo Faveri, DDS, PhD., Principal Investigator, Affiliation: University of Guarulhos Magda Feres, DDS, PhD., Principal Investigator, Affiliation: University of Guarulhos Luciene C Figueiredo, DDS, PhD., Principal Investigator, Affiliation: University of Guarulhos
Summary
Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX)
and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and
microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with
ChP. However, the effects of this antibiotic protocol have not been directly compared in
non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical
and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and
non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers
would benefit better from this combination of therapies than the smokers.
Clinical Details
Official title: Clinical and Microbiological Effects of Adjunctive Metronidazole Plus Amoxicillin in the Treatment of Generalized Chronic Periodontitis: Smokers Versus Non-Smokers.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean clinical attachment level change post- scaling and root planing in sites with initial probing depth ≥ 7 mm
Secondary outcome: Number of subjects with low, moderate and high risk for disease progression.Mean full-mouth clinical attachment level. Mean full-mouth probing depth. Mean clinical attachment level change post-scaling and root planing in sites with initial probing depth between 4-6 mm Mean probing depth reduction post-scaling and root planing in sites with initial probing depth between 4-6 mm Mean probing depth reduction post-scaling and root planing in sites with initial probing depth ≥ 7 mm Mean changes in levels of the 40 bacterial species evaluated by Checherboard DNA-DNA hybridization Mean changes in proportions of the 40 bacterial species evaluated by Checherboard DNA-DNA hybridization
Detailed description:
Sample size calculation:
This study is designed to compare the clinical and microbiological effects of the treatment
of smoker and non-smoker subjects with SRP+MTZ+AMX. The ideal sample size to assure adequate
power for this clinical trial was calculated considering differences of at least 1mm between
groups for clinical attachment level (CAL) in initially deep periodontal sites (PD ≥ 7 mm).
It was also determined that the standard deviation of CAL change at deep sites would be 1. 0
mm based on our earlier studies of smokers and non-smokers receiving SRP combined with
MTZ+AMX. Based on these calculations, it was defined that 26 subjects per group would be
necessary to provide an 85% power with an α of 0. 01. Considering an attrition of about 20%,
it was established that at least 32 subjects should be included in each treatment group.
Experimental design and treatment protocol:
In this cohort clinical trial, subjects will be assigned according to their smoking status,
into smoker and non-smoker groups. All subjects will receive SRP combined with systemic MTZ
(400 mg) and AMX (500 mg). Both antibiotics will be administered T. I.D. for 14 days. Before
the study begins, all subjects will receive full-mouth supragingival scaling and instruction
on proper home-care techniques. They will receive the same dentifrice to use during the
study period (Colgate Total). All subjects will receive full-mouth SRP performed under local
anesthesia in four to six appointments lasting approximately 1h each. Treatment of the
entire oral cavity will be done in 14 days. SRP will be performed by one trained
periodontist using manual instruments. The antibiotic therapies will start immediately after
the first session of mechanical instrumentation. The University Pharmacy will prepare the
antibiotic pills and send them to the study coordinator, who will mark the code number of
each subject on a set of two packs and give them to the examiner. All subjects will receive
clinical and microbiological monitoring at baseline and at 3, 6 and 12 months post-therapy.
Clinical monitoring:
One calibrated examiner will perform clinical monitoring and the treatment will carried out
by another clinician. Thus, the examiner and the clinician will be masked as to the nature
of the treatment groups. Visible plaque (presence or absence), gingival bleeding (presence
or absence), bleeding on probing (BOP; presence or absence), suppuration (presence or
absence), PD (mm) and clinical attachment level (CAL, mm) will be measured at six sites per
tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual) in all
teeth, excluding third molars. The PD and CAL measurements will be recorded to the nearest
millimeter using a North Carolina periodontal probe.
Microbiological Monitoring:
Subgingival plaque samples will be collected at baseline and at 3, 6 and 12 months post-SRP
from nine non-contiguous interproximal sites per subject. The select sites will be
randomized in different quadrants and subset according to baseline PD, three samples in each
of the following categories: shallow (PD<3 mm), intermediate (PD 4-6 mm) and deep (PD>7 mm).
After the clinical parameters have been recorded, the supragingival plaque will be removed
and the subgingival samples will be taken with individual sterile curettes (Gracey #11-12)
and immediately placed in separate Eppendorf tubes containing 0. 15 ml of buffer (TE). One
hundred microliters of 0. 5 M sodium hydroxide (NaOH) will be added to each tube and the
samples will be dispersed using a vortex mixer. The samples will be analyzed by Checkerboard
DNA-DNA hybridization.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic periodontitis (AAP 1999);
- ≥35 years of age;
- Presence of at least 15 teeth;
- Minimum of 6 teeth with at least one site each with 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).
- Smokers: had smoked at least 10 cigarettes per day for a minimum of 5 years;
- Non-smokers: had never smoked.
Exclusion Criteria:
- Previous subgingival periodontal therapy;
- Pregnancy;
- Nursing;
- Systemic diseases that could affect the progression of periodontal disease (e. g.
diabetes, osteoporosis);
- Long-term administration of anti - inflammatory medications;
- Need for antibiotic pre-medication for routine dental therapy;
- Continuous use of mouthrinses containing antimicrobials;
- Antibiotic therapy in the previous 6 months
- Allergy to MTZ or AMX.
Locations and Contacts
University of Guarulhos, Guarulhos, São Paulo/ SP 07023-070, Brazil
Additional Information
Starting date: July 2011
Last updated: April 17, 2013
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