Chronic PeriodontitisPhase 4NCT00805558
Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
A Phase 4 study testing moxifloxacin and Ciprofloxacin plus metronidazole in people with Chronic Periodontitis, run by Facultad Nacional de Salud Publica at 1 site in Colombia.
Trial summary
The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- moxifloxacin and Ciprofloxacin plus metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and up
- clinical and radiographic signs of severe (CAL 5 mm or more) chronic periodontitis.
- at least 20 natural teeth in situ
- pocket probing depths (PPDs) of ≥ 5 mm at a minimum of eight tooth sites
- willingness to participate and to be available at all times required for participation
- over 30% of the teeth present must have a PPDs)≥ 4 mm and insertion loss ≥ 5 mm evaluated by an experienced periodontist
- informed consent signed by the patient
Who cannot join
- if they (or parents or siblings) show confirmed or assumed allergies or hyper-sensitive skin reactions against moxifloxacin, ciprofloxacin (or other quinolones as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics"
- subjects who have undergone antibiotic therapy three months before the start of the study under interrogation
- have Down's syndrome
- known AIDS/HIV
- regularly take systemic medication affecting the periodontal conditions, e.g. phenytoin, nifedipine, and/or steroid drugs
- professional periodontal therapy during 6 months prior to baseline
- require antibiotic treatment for dental appointments
- are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Faculta Nacional de Salud Publica Universidad de Antioquia
Medellín, Antioquia, 057-4
About this study
Official title: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis.
Read the detailed description
Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial.However, bearing in mind that Colombia has reported the frequent presence of Enterobacteriaceae (Klebsiella and Enterobacter) in subgingival plaque of patients with chronic periodontitis, the response to treatment may be different.The enteric have shown resistance to amoxicillin, amoxicillin / clavulanate, metronidazole and tetracycline in studies conducted in the United States, Norway, Brazil and Colombia.Although the combination ciprofloxacin metronidazole has been recommended in the dental literature are not known publications that demonstrate its effectiveness against periodontopathogens and enteric present in subgingival plaque of subjects with chronic periodontitis.On the other hand, some in vitro studies have demonstrated the effectiveness of moxifloxacin against periodontopathogens, but was not aware of any clinical trials or in vitro studies on antibiotic resistance and susceptibility to enteric isolated subgingival plaque of patients with chronic periodontitis in which employs moxifloxacin.
- Conditions
- Chronic Periodontitis
- Being tested
- moxifloxacin, Ciprofloxacin plus metronidazole
- Keywords
- Chronic Periodontitis, antibiotics
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
Also called Moxifloxacin hydrochloride
400 mg moxifloxacin once daily for 7 days
Ciprofloxacin plus metronidazoleDrug
Also called ciprofloxacino, metronidazole benzoato
Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days. Receives: Drug: moxifloxacin |
| Ciprofloxacin plus metronidazole | Active comparator | Scaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days Receives: Drug: Ciprofloxacin plus metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Measured: six months period (two measurements)
Secondary outcomes (2)
Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score.
Measured: six months
Microbial colonization dynamic
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facultad Nacional de Salud Publica
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Investigators
- Carlos M Ardila, DDS Cand PhD, Principal investigator, Grupo Epidemiologia Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805558
- Sponsor's protocol ID
- ARD-0001-CM
- Other IDs
- CBEIH-SIU 08-44-203
- Status last verified
- Oct 2009
- First submitted
- 8 Dec 2008
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ardila CM, Fernandez N, Guzman IC. Antimicrobial susceptibility of moxifloxacin against gram-negative enteric rods from colombian patients with chronic periodontitis. J Periodontol. 2010 Feb;81(2):292-9. doi: 10.1902/jop.2009.090464.
PubMed 20151809Ardila CM, Lopez MA, Guzman IC. High resistance against clindamycin, metronidazole and amoxicillin in Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans isolates of periodontal disease. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e947-51.
PubMed 20383102Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
PubMed 33197289
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT00805558
- Acronym / sponsor ID
- ARD-0001-CM
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Facultad Nacional de Salud PublicaUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis.
Detailed description
Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial.However, bearing in mind that Colombia has reported the frequent presence of Enterobacteriaceae (Klebsiella and Enterobacter) in subgingival plaque of patients with chronic periodontitis, the response to treatment may be different.The enteric have shown resistance to amoxicillin, amoxicillin / clavulanate, metronidazole and tetracycline in studies conducted in the United States, Norway, Brazil and Colombia.Although the combination ciprofloxacin metronidazole has been recommended in the dental literature are not known publications that demonstrate its effectiveness against periodontopathogens and enteric present in subgingival plaque of subjects with chronic periodontitis.On the other hand, some in vitro studies have demonstrated the effectiveness of moxifloxacin against periodontopathogens, but was not aware of any clinical trials or in vitro studies on antibiotic resistance and susceptibility to enteric isolated subgingival plaque of patients with chronic periodontitis in which employs moxifloxacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: moxifloxacinScaling and root planing plus 400 mg moxifloxacin once daily for 7 days. |
| Ciprofloxacin plus metronidazole | Active comparator | Drug: Ciprofloxacin plus metronidazoleScaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and up
- clinical and radiographic signs of severe (CAL 5 mm or more) chronic periodontitis.
- at least 20 natural teeth in situ
- pocket probing depths (PPDs) of ≥ 5 mm at a minimum of eight tooth sites
- willingness to participate and to be available at all times required for participation
Key exclusion criteria (8 listed)
- if they (or parents or siblings) show confirmed or assumed allergies or hyper-sensitive skin reactions against moxifloxacin, ciprofloxacin (or other quinolones as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics"
- subjects who have undergone antibiotic therapy three months before the start of the study under interrogation
- have Down's syndrome
- known AIDS/HIV
- regularly take systemic medication affecting the periodontal conditions, e.g. phenytoin, nifedipine, and/or steroid drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moxifloxacinAlso: Moxifloxacin hydrochloride400 mg moxifloxacin once daily for 7 days | Drug | Moxifloxacin |
| Ciprofloxacin plus metronidazoleAlso: ciprofloxacino, metronidazole benzoatoCiprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days | Drug | Ciprofloxacin plus metronidazole |
Primary outcome
Probing Depth
Time frame: six months period (two measurements)
2 secondary outcomes
Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score.
Time frame: six months
Microbial colonization dynamic
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Results publication: PubMed 20151809Ardila CM, Fernandez N, Guzman IC. Antimicrobial susceptibility of moxifloxacin against gram-negative enteric rods from colombian patients with chronic periodontitis. J Periodontol. 2010 Feb;81(2):292-9. doi: 10.1902/jop.2009.090464.
- Results publication: PubMed 20383102Ardila CM, Lopez MA, Guzman IC. High resistance against clindamycin, metronidazole and amoxicillin in Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans isolates of periodontal disease. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e947-51.
- Derived from this study: PubMed 33197289Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
- Clinical trial of moxifloxacin in chronic periodontitisLink provided by the sponsor.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos M Ardila, DDS Cand PhD principal investigator
Grupo Epidemiologia Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing moxifloxacin and Ciprofloxacin plus metronidazole in people with Chronic Periodontitis, run by Facultad Nacional de Salud Publica at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (time frame: six months period (two measurements)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.