Chronic PeriodontitisMOMENTNCT02954393
Amoxicillin and Metronidazole During Periodontal Treatment
A study testing Scaling and root planing, Metronidazole active phase and Metronidazole healing phase in people with Chronic Periodontitis, run by Belén Retamal-Valdes at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Scaling and root planing, Metronidazole active phase and Metronidazole healing phase
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2015to Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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).
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Guarulhos
Guarulhos, São Paulo, 07023-070
University of São Paulo
São Paulo, 05508-000
About this study
Official title: Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
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.
Read the 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%.
- Conditions
- Chronic Periodontitis
- Being tested
- Scaling and root planing, Metronidazole active phase, Metronidazole healing phase, Amoxicillin active phase, Amoxicillin healing phase
- Keywords
- Periodontal disease, Metronidazole, Amoxicillin, Scaling and root planing, Healing phase
- Medical subject headings
- Chronic Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Also called SRP
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.
Metronidazole active phaseDrug
Also called MTZ 1
Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Metronidazole healing phaseDrug
Also called MTZ 2
Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Amoxicillin active phaseDrug
Also called AMX 1
Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Amoxicillin healing phaseDrug
Also called AMX 2
Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Placebos active phaseDrug
Also called P 1
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Placebos healing phaseDrug
Also called P 2
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days. Receives: Procedure: Scaling and root planing; Drug: Placebos active phase; Drug: Placebos healing phase |
| Active phase | Active comparator | 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. Receives: Procedure: Scaling and root planing; Drug: Metronidazole active phase; Drug: Amoxicillin active phase; Drug: Placebos healing phase |
| Healing phase | Active comparator | 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. Receives: Procedure: Scaling and root planing; Drug: Metronidazole healing phase; Drug: Amoxicillin healing phase; Drug: Placebos active phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Measured: 12 months
Secondary outcomes (24)
Number of sites with PD ≥ 5 mm.
Measured: Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 6 mm.
Measured: Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 7 mm.
Measured: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 5 mm.
Measured: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 6 mm.
Measured: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 7 mm.
Measured: Baseline, 3, 6 and 12 months.
Mean PD changes in sites with initial PD between 4-6 mm
Measured: Baseline - 12 months.
Mean PD changes in sites with initial PD ≥ 7 mm.
Measured: Baseline - 12 months.
Mean CAL changes in sites with initial CAL between 4-6 mm
Measured: Baseline - 12 months.
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Measured: Baseline - 12 months.
Full-mouth PD.
Measured: Baseline, 3, 6 and 12 months.
Full-mouth clinical attachment level.
Measured: Baseline, 3, 6 and 12 months.
Percentage of sites with bleeding on probing.
Measured: Baseline, 3, 6 and 12 months.
Percentage of sites with plaque accumulation
Measured: Baseline, 3, 6 and 12 months.
Percentage of sites with marginal bleeding.
Measured: Baseline, 3, 6 and 12 months.
Occurrence of headache obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic.
Proportions of periodontal pathogenic bacterial species.
Measured: Baseline, 3, 6 and 12 months.
Counts of periodontal pathogenic bacterial species.
Measured: Baseline, 3, 6 and 12 months.
Counts of chemokines in the crevicular gingival fluid.
Measured: Baseline and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2019
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belén Retamal-Valdes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belén Retamal-Valdes, University of Guarulhos
- Investigators
- Magda Feres, Professor, Study chair, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954393
- Sponsor's protocol ID
- CAAE: 32465714.4.1001.5506
- Acronym
- MOMENT
- Status last verified
- Jan 2020
- First submitted
- 1 Nov 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PubMed 10863370Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.
PubMed 23016867Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.
PubMed 25494600Haffajee AD, Patel M, Socransky SS. Microbiological changes associated with four different periodontal therapies for the treatment of chronic periodontitis. Oral Microbiol Immunol. 2008 Apr;23(2):148-57. doi: 10.1111/j.1399-302X.2007.00403.x.
PubMed 18279183Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.8.x.
PubMed 12787214Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.
PubMed 25142259Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.
PubMed 15643744Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.
PubMed 18549447Matuliene G, Studer R, Lang NP, Schmidlin K, Pjetursson BE, Salvi GE, Bragger U, Zwahlen M. Significance of Periodontal Risk Assessment in the recurrence of periodontitis and tooth loss. J Clin Periodontol. 2010 Feb;37(2):191-9. doi: 10.1111/j.1600-051X.2009.01508.x. Epub 2009 Dec 21.
PubMed 20041980Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.
PubMed 20447259Mestnik MJ, Feres M, Figueiredo LC, Soares G, Teles RP, Fermiano D, Duarte PM, Faveri M. The effects of adjunctive metronidazole plus amoxicillin in the treatment of generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Oct;39(10):955-61. doi: 10.1111/j.1600-051X.2012.01932.x. Epub 2012 Aug 6.
PubMed 22882646Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Oct;83(10):1257-69. doi: 10.1902/jop.2012.110625. Epub 2012 Feb 14.
PubMed 22220767Socransky SS, Haffajee AD. Dental biofilms: difficult therapeutic targets. Periodontol 2000. 2002;28:12-55. doi: 10.1034/j.1600-0757.2002.280102.x. No abstract available.
PubMed 12013340Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. doi: 10.1111/j.1600-0757.2005.00107.x. No abstract available.
PubMed 15853940Socransky SS, Haffajee AD, Cugini MA, Smith C, Kent RL Jr. Microbial complexes in subgingival plaque. J Clin Periodontol. 1998 Feb;25(2):134-44. doi: 10.1111/j.1600-051x.1998.tb02419.x.
PubMed 9495612
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02954393
- Acronym / sponsor ID
- MOMENT / CAAE: 32465714.4.1001.5506
- Conditions
- Chronic Periodontitis
- Keywords
- Periodontal disease, Metronidazole, Amoxicillin, Scaling and root planing, Healing phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Belén Retamal-ValdesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Nov 2016 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Scaling and root planing, Drug: Placebos active phase, Drug: Placebos healing phaseScaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days. |
| Active phase | Active comparator | Procedure: Scaling and root planing, Drug: Metronidazole active phase, Drug: Amoxicillin active phase, Drug: Placebos healing phaseScaling 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. |
| Healing phase | Active comparator | Procedure: Scaling and root planing, Drug: Metronidazole healing phase, Drug: Amoxicillin healing phase, Drug: Placebos active phaseScaling 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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).
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Scaling and root planingAlso: SRPSRP 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. | Procedure or surgery | Active phase, Control, Healing phase |
| Metronidazole active phaseAlso: MTZ 1Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session). | Drug | Active phase |
| Metronidazole healing phaseAlso: MTZ 2Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase). | Drug | Healing phase |
| Amoxicillin active phaseAlso: AMX 1Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session). | Drug | Active phase |
| Amoxicillin healing phaseAlso: AMX 2Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase). | Drug | Healing phase |
| Placebos active phaseAlso: P 1Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session). | Drug | Control, Healing phase |
| Placebos healing phaseAlso: P 2Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase). | Drug | Active phase, Control |
Primary outcome
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Time frame: 12 months
24 secondary outcomes
Number of sites with PD ≥ 5 mm.
Time frame: Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 6 mm.
Time frame: Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 7 mm.
Time frame: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 5 mm.
Time frame: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 6 mm.
Time frame: Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 7 mm.
Time frame: Baseline, 3, 6 and 12 months.
Mean PD changes in sites with initial PD between 4-6 mm
Time frame: Baseline - 12 months.
Mean PD changes in sites with initial PD ≥ 7 mm.
Time frame: Baseline - 12 months.
Mean CAL changes in sites with initial CAL between 4-6 mm
Time frame: Baseline - 12 months.
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Time frame: Baseline - 12 months.
Full-mouth PD.
Time frame: Baseline, 3, 6 and 12 months.
Full-mouth clinical attachment level.
Time frame: Baseline, 3, 6 and 12 months.
Percentage of sites with bleeding on probing.
Time frame: Baseline, 3, 6 and 12 months.
Percentage of sites with plaque accumulation
Time frame: Baseline, 3, 6 and 12 months.
Percentage of sites with marginal bleeding.
Time frame: Baseline, 3, 6 and 12 months.
Occurrence of headache obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Proportions of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months.
Counts of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months.
Counts of chemokines in the crevicular gingival fluid.
Time frame: Baseline and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 10863370Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
- Background: PubMed 23016867Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.
- Background: PubMed 25494600Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.
- Background: PubMed 18279183Haffajee AD, Patel M, Socransky SS. Microbiological changes associated with four different periodontal therapies for the treatment of chronic periodontitis. Oral Microbiol Immunol. 2008 Apr;23(2):148-57. doi: 10.1111/j.1399-302X.2007.00403.x.
- Background: PubMed 12787214Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.8.x.
- Background: PubMed 25142259Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.
- Background: PubMed 15643744Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.
- Background: PubMed 18549447Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.
- Background: PubMed 20041980Matuliene G, Studer R, Lang NP, Schmidlin K, Pjetursson BE, Salvi GE, Bragger U, Zwahlen M. Significance of Periodontal Risk Assessment in the recurrence of periodontitis and tooth loss. J Clin Periodontol. 2010 Feb;37(2):191-9. doi: 10.1111/j.1600-051X.2009.01508.x. Epub 2009 Dec 21.
- Background: PubMed 20447259Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.
- Background: PubMed 22882646Mestnik MJ, Feres M, Figueiredo LC, Soares G, Teles RP, Fermiano D, Duarte PM, Faveri M. The effects of adjunctive metronidazole plus amoxicillin in the treatment of generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Oct;39(10):955-61. doi: 10.1111/j.1600-051X.2012.01932.x. Epub 2012 Aug 6.
- Background: PubMed 22220767Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Oct;83(10):1257-69. doi: 10.1902/jop.2012.110625. Epub 2012 Feb 14.
- Individual participant dataSharing planned: No
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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.
Magda Feres, Professor study chair
University of Guarulhos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing, Metronidazole active phase and Metronidazole healing phase in people with Chronic Periodontitis, run by Belén Retamal-Valdes at 2 sites in Brazil.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (time frame: 12 months). 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 NCT02954393, which also lists 20 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 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.