PeriodontitisNCT06177119
Amoxicillin and Metronidazole During or After the Periodontal Treatment
A study testing Scaling and root planing, Metronidazole during SRP and Amoxicillin during SRP in people with Periodontitis, run by Belén Retamal-Valdes at 1 site in Brazil.
Trial summary
This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing, Metronidazole during SRP and Amoxicillin during SRP
- 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
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2012to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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 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
1 site in 1 country.
About this study
Official title: Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis: Clinical and Microbiological Evaluation
This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.
Read the detailed description
Scaling and root planing (SRP) is the most used periodontal therapy for periodontal treatment. Despite leading, in most cases, to an improvement in periodontal clinical parameters, SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health, especially in cases of more advanced and generalized diseases. Thus, other therapies supporting SRP, such as systemic antibiotics, have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy. Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics, especially the association of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of severe periodontitis. However, some essential issues associated with the use of these antibiotics remain to be established. Therefore, the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Seventy-two subjects with severe periodontitis were selected and randomized into two groups (n = 36 / group) - Test 1 (T1): SRP in 14 days, associated with the concomitant use of AMX (500mg, 3x / day) and MTZ (400mg 3x / day) for 14 days; and Test 2 (T2): SRP in 14 days, associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days. All volunteers received clinical and microbiological evaluation at baseline, 3, 6 and 12 months post-SRP. Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes were performed using adjustments for multiple comparisons. Statistical significance was set at 5%.
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing, Placebos during SRP, Placebos after SRP, Metronidazole during SRP, Amoxicillin during SRP
- Keywords
- periodontitis, scaling and root planing, metronidazole, amoxicillin, treatment, microbiota
- Medical subject headings
- Periodontitis
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.
Placebos during SRPDrug
Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session.
Placebos after SRPDrug
Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session.
Metronidazole during SRPDrug
Metronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session.
Amoxicillin during SRPDrug
Amoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session.
Metronidazole after SRPDrug
Metronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session.
Amoxicillin after SRPDrug
Amoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session.
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session Receives: Procedure: Scaling and root planing; Drug: Placebos after SRP; Drug: Metronidazole during SRP; Drug: Amoxicillin during SRP |
| Test 2 | Experimental | Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days. Receives: Procedure: Scaling and root planing; Drug: Placebos during SRP; Drug: Metronidazole after SRP; Drug: Amoxicillin after SRP |
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.
Measured: 12 months
Secondary outcomes (23)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start31 Jan 2012
- Primary completion1 Jul 2012
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
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
- Marcelo Faveri, Professor, Study chair, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177119
- Sponsor's protocol ID
- SISNEP/726_Jan31_2012
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
PubMed 29926490Feres M, Retamal-Valdes B, Faveri M, Duarte P, Shibli J, Soares GMS, Miranda T, Teles F, Goodson M, Hasturk H, Van Dyke T, Ehmke B, Eickholz P, Schlagenhauf U, Meyle J, Koch R, Kocher T, Hoffmann T, Kim TS, Kaner D, Figueiredo LC, Doyle H. Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach. J Int Acad Periodontol. 2020 Apr 1;22(2):41-53.
PubMed 32224549Feres 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 25494600Feres 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 23016867Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Wang X, Figueiredo LC, Feres M. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a secondary analysis of microbiological results from a randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):366-76. doi: 10.1111/jcpe.12217.
PubMed 24834504Faveri M, Figueiredo LC, Feres M. Treatment of chronic periodontitis may be improved by the adjunctive use of systemic metronidazole. J Evid Based Dent Pract. 2014 Jun;14(2):70-2. doi: 10.1016/j.jebdp.2014.04.025. Epub 2014 Apr 12. No abstract available.
PubMed 24913531Feres M, Faveri M, Figueiredo LC, Teles R, Flemmig T, Williams R, Lang NP. Group B. Initiator paper. Non-surgical periodontal therapy: mechanical debridement, antimicrobial agents and other modalities. J Int Acad Periodontol. 2015 Jan;17(1 Suppl):21-30. No abstract available.
PubMed 25764587Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.
PubMed 28303587Teughels W, Feres M, Oud V, Martin C, Matesanz P, Herrera D. Adjunctive effect of systemic antimicrobials in periodontitis therapy: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:257-281. doi: 10.1111/jcpe.13264.
PubMed 31994207Feres M, Retamal-Valdes B, Fermiano D, Faveri M, Figueiredo LC, Mayer MPA, Lee JJ, Bittinger K, Teles F. Microbiome changes in young periodontitis patients treated with adjunctive metronidazole and amoxicillin. J Periodontol. 2021 Apr;92(4):467-478. doi: 10.1002/JPER.20-0128. Epub 2020 Oct 12.
PubMed 32844406
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis: Clinical and Microbiological Evaluation
- ClinicalTrials.gov ID
- NCT06177119
- Acronym / sponsor ID
- SISNEP/726_Jan31_2012
- Conditions
- Periodontitis
- Keywords
- periodontitis, scaling and root planing, metronidazole, amoxicillin, treatment, microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Belén Retamal-ValdesUniversity, hospital or other
- Study start
- 31 Jan 2012 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- 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.
This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.
Detailed description
Scaling and root planing (SRP) is the most used periodontal therapy for periodontal treatment. Despite leading, in most cases, to an improvement in periodontal clinical parameters, SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health, especially in cases of more advanced and generalized diseases. Thus, other therapies supporting SRP, such as systemic antibiotics, have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy. Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics, especially the association of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of severe periodontitis. However, some essential issues associated with the use of these antibiotics remain to be established. Therefore, the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Seventy-two subjects with severe periodontitis were selected and randomized into two groups (n = 36 / group) - Test 1 (T1): SRP in 14 days, associated with the concomitant use of AMX (500mg, 3x / day) and MTZ (400mg 3x / day) for 14 days; and Test 2 (T2): SRP in 14 days, associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days. All volunteers received clinical and microbiological evaluation at baseline, 3, 6 and 12 months post-SRP. Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes were performed using adjustments for multiple comparisons. Statistical significance was set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Procedure: Scaling and root planing, Drug: Placebos after SRP, Drug: Metronidazole during SRP, Drug: Amoxicillin during SRPScaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session |
| Test 2 | Experimental | Procedure: Scaling and root planing, Drug: Placebos during SRP, Drug: Metronidazole after SRP, Drug: Amoxicillin after SRPScaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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 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 | Test 1, Test 2 |
| Placebos during SRPAmoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session. | Drug | Test 2 |
| Placebos after SRPAmoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session. | Drug | Test 1 |
| Metronidazole during SRPMetronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session. | Drug | Test 1 |
| Amoxicillin during SRPAmoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session. | Drug | Test 1 |
| Metronidazole after SRPMetronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session. | Drug | Test 2 |
| Amoxicillin after SRPAmoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session. | Drug | Test 2 |
Primary outcome
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm.
Time frame: 12 months
23 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 29926490Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
- Background: PubMed 32224549Feres M, Retamal-Valdes B, Faveri M, Duarte P, Shibli J, Soares GMS, Miranda T, Teles F, Goodson M, Hasturk H, Van Dyke T, Ehmke B, Eickholz P, Schlagenhauf U, Meyle J, Koch R, Kocher T, Hoffmann T, Kim TS, Kaner D, Figueiredo LC, Doyle H. Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach. J Int Acad Periodontol. 2020 Apr 1;22(2):41-53.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 24834504Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Wang X, Figueiredo LC, Feres M. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a secondary analysis of microbiological results from a randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):366-76. doi: 10.1111/jcpe.12217.
- Results publication: PubMed 24913531Faveri M, Figueiredo LC, Feres M. Treatment of chronic periodontitis may be improved by the adjunctive use of systemic metronidazole. J Evid Based Dent Pract. 2014 Jun;14(2):70-2. doi: 10.1016/j.jebdp.2014.04.025. Epub 2014 Apr 12. No abstract available.
- Results publication: PubMed 25764587Feres M, Faveri M, Figueiredo LC, Teles R, Flemmig T, Williams R, Lang NP. Group B. Initiator paper. Non-surgical periodontal therapy: mechanical debridement, antimicrobial agents and other modalities. J Int Acad Periodontol. 2015 Jan;17(1 Suppl):21-30. No abstract available.
- Results publication: PubMed 28303587Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.
- Results publication: PubMed 31994207Teughels W, Feres M, Oud V, Martin C, Matesanz P, Herrera D. Adjunctive effect of systemic antimicrobials in periodontitis therapy: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:257-281. doi: 10.1111/jcpe.13264.
- Results publication: PubMed 32844406Feres M, Retamal-Valdes B, Fermiano D, Faveri M, Figueiredo LC, Mayer MPA, Lee JJ, Bittinger K, Teles F. Microbiome changes in young periodontitis patients treated with adjunctive metronidazole and amoxicillin. J Periodontol. 2021 Apr;92(4):467-478. doi: 10.1002/JPER.20-0128. Epub 2020 Oct 12.
- 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.
Marcelo Faveri, Professor study chair
University of Guarulhos
1 site 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 during SRP and Amoxicillin during SRP in people with Periodontitis, run by Belén Retamal-Valdes at 1 site 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 20 Dec 2023. 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 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. 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. (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 NCT06177119, which also lists 10 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 20 Dec 2023.