Chronic PeriodontitisPhase 4Metro + AmoxiNCT01211223
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
A Phase 4 study testing Administration of Metronidazole plus Amoxicillin in people with Chronic Periodontitis and Clinical and Microbiological Effects, run by University of Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Periodontitis, Clinical and Microbiological Effects
- What is being tested?
- Administration of Metronidazole plus Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChile
- Study dates
- Jan 2010to Mar 2014
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
- Being tested
- Administration of Metronidazole plus Amoxicillin
- Keywords
- Chronic periodontitis, Metronidazole plus Amoxicillin, Mechanical periodontal therapy, Scaling and Root Planning, Periodontal treatment
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Metronidazole plus AmoxicillinDrug
Metronidazole plus Amoxicillin after, during and after root planning
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planning + placebo + antibiotics | Experimental | * Scaling and root planning + placebo
* Scaling and root planning + metronidazole plus amoxicillin
* Metronidazole plus amoxicillin + scaling and root planning Receives: Drug: Administration of Metronidazole plus Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Mean change in clinical attachment level (CAL)
Measured: 12 months
Secondary outcomes (1)
- Mean change in probing pocket depths (PD)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Jorge Gamonal, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211223
- Sponsor's protocol ID
- Facultad Odontologia, U Chile
- Acronym
- Metro + Amoxi
- Status last verified
- Jun 2016
- First submitted
- 28 Sep 2010
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01211223
- Acronym / sponsor ID
- Metro + Amoxi / Facultad Odontologia, U Chile
- Keywords
- Chronic periodontitis, Metronidazole plus Amoxicillin, Mechanical periodontal therapy, Scaling and Root Planning, Periodontal treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Sep 2010 (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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planning + placebo + antibiotics | Experimental | Drug: Administration of Metronidazole plus Amoxicillin* Scaling and root planning + placebo * Scaling and root planning + metronidazole plus amoxicillin * Metronidazole plus amoxicillin + scaling and root planning |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Administration of Metronidazole plus AmoxicillinMetronidazole plus Amoxicillin after, during and after root planning | Drug | Scaling and root planning + placebo + antibiotics |
Primary outcome
- Mean change in clinical attachment level (CAL)
Time frame: 12 months
1 secondary outcome
- Mean change in probing pocket depths (PD)
Time frame: 12 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 16 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Administration of Metronidazole plus Amoxicillin in people with Chronic Periodontitis and Clinical and Microbiological Effects, run by University of Chile at 1 site in Chile.
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 1 inclusion and 1 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 16 Jun 2016. 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 Chile. 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?
- Mean change in clinical attachment level (CAL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2016.