PeriodontitisNCT05934227
Amoxicillin Plus Metronidazole in Periodontal Maintenance
A study testing Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams in people with Periodontitis and Periodontal Pocket, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Gum disease require a lifetime supportive periodontal care aiming at preventing additional inflammation and bone resorption. During this phase it is also relevant to keep germs under acceptable levels through proper daily hygiene although patient's cooperation tends to decrease over time. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Periodontitis, Periodontal Pocket
- What is being tested?
- Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 1 Sep 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals under a PMT program
- monitored over ~13 years of consecutive recall visits (from August 2009 to May 2023).
- individuals reclassified as stage III and IV periodontitis
- not having presented the following clinical endpoint in two consecutive PMT visits - presence of ≤4 sites with PD ≥5 mm
- non-diabetics
- non-smokers
- no antibiotic use for any purpose within 3 months prior to entering the study
Who cannot join
- pregnant or lactating women
- smokers
- presence of systemic diseases that could affect the progression of periodontitis long-term administration of anti-inflammatory drugs,
- need for antibiotic premedication for routine dental therapy and
- allergy to metronidazole or amoxicillin
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais, Dental School
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Long-term Effects of Sub Gingival Debridement Associated With Antibiotics in Individual Undergoing Maintenance Periodontal Therapy
Gum disease require a lifetime supportive periodontal care aiming at preventing additional inflammation and bone resorption. During this phase it is also relevant to keep germs under acceptable levels through proper daily hygiene although patient's cooperation tends to decrease over time.
There are conflicting opinions regarding combination of dental scaling with antibiotics. This is why the present study was designed to evaluate the clinical and microbiological effects of combined therapy 1 year following supportive periodontal care. Fifty patients who voluntarily decide to participate will receive dental scaling associated with two different antibiotics or placebo capsules. Paper points will be used to collect dental plaque samples and levels of bacteria will be determined. Dental specialists will also perform clinical examinations. Patients would be available for 4 dental appointments: prior to and 3, 6 and 12 months after dental scaling.
Read the detailed description
The benefits of amoxicillin (AMX) plus metronidazole (MTZ) adjunctive to scaling and root planing (SRP) require further investigation, particularly in individuals with a high occurrence of recurrent periodontal pockets under periodontal maintenance therapy (PMT). The aim of the study was to evaluate the clinical and microbiological outcomes of systemic AMX+MTZ adjunctive to SRP in patients with recurring sites [probing depth (PD) ≥5 mm) under PMT, after 1 year of follow-up, compared to SRP alone.
Methods: A randomized controlled clinical trial will be conducted with 50 individuals in a PMT program, which will be randomly allocate in two groups: control group (SRP and placebo; n=24) and test group (SRP and systemic MTZ+AMX; n=23). Participants of the present study will be selected from an open cohort study comprising individuals under a PMT program, who were monitored over 12 years of consecutive recall visits (from August 2009 to April 2023). Periodontal clinical parameters and subgingival biofilm samples will be collected by trained and calibrated examiners at baseline (T1), 3 (T2), 6 (T3) and 12 (T4) months after treatment. Microbiological analyses will be performed at T1, T2 and T4 by real-time quantitative polymerase chain reaction.
The percentage of residual pockets will be listed. Additionally, an overall mean PD value will be calculated for the treated sites initially measuring ≥ 5mm and clinical attachment loss (CAL) ≥ 3mm. Statistical testing for normality with respect to the distribution of study outcomes (clinical parameters) will be performed using the Kolmogorov-Smirnov test. Parametric and non-parametric tests (Chi-squared, Wilcoxon and Friedman tests) will be performed when appropriate. Spearman's correlation (r) will be used to evaluate the relationship between bacterial counts and periodontal condition between groups and evaluation times. All analyses will be performed using statistical software Statistical Package for the Social Sciences (SPSS) (p < 0.05).
- Conditions
- Periodontitis, Periodontal Pocket
- Being tested
- Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams, placebo
- Keywords
- amoxicillin, dental scaling, metronidazole, periodontal maintenance, periodontitis, root planing
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 500 milligrams capsules plus metronidazole 400 milligramsDrug
Also called Amoxicillin Trihydrate, Amoxil
supra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of amoxicillin (500 milligrams) + metronidazole (400 milligrams) three times a day for 7 days after SRP
placeboOther
supra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of placebo containing corn starch capsules three times a day for 7 days after SRP
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 1) scaling and root planing (SRP) plus systemic administration of placebo (n=25) Receives: Other: placebo |
| antibiotics | Experimental | 2) scaling and root planing (SRP) plus systemic administration of amoxicillin and metronidazole (n=25). Receives: Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole-mouth periodontal pocket depth improvement
mean pocket depth (PD) in millimeters
Measured: baseline and 12 months
changes in percentage of deep periodontal pocket
proportion of sites with PD ≥5 millimeters
Measured: baseline and 12 months
Secondary outcomes (2)
total bacterial load in sub gingival samples
mean total bacterial load
Measured: baseline and 3 months
levels of target species in sub gingival samples
mean levels of periodontal pathogens
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- After clinical examination, participants will be randomly allocated into two treatment groups: 1) control group (SRP) - systemic administration of placebo after SRP (n = 25); 2) test group (SRP+AMX+MTZ) - systemic administration of AMX+MTZ after SRP (n=25).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fernando O Costa, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, PhD, Principal investigator, Titular Professor in periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934227
- Sponsor's protocol ID
- 5.957.583
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Sub Gingival Debridement Associated With Antibiotics in Individual Undergoing Maintenance Periodontal Therapy
- ClinicalTrials.gov ID
- NCT05934227
- Acronym / sponsor ID
- 5.957.583
- Conditions
- Periodontitis, Periodontal Pocket
- Keywords
- amoxicillin, dental scaling, metronidazole, periodontal maintenance, periodontitis, root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Jul 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.
Gum disease require a lifetime supportive periodontal care aiming at preventing additional inflammation and bone resorption. During this phase it is also relevant to keep germs under acceptable levels through proper daily hygiene although patient's cooperation tends to decrease over time.
There are conflicting opinions regarding combination of dental scaling with antibiotics. This is why the present study was designed to evaluate the clinical and microbiological effects of combined therapy 1 year following supportive periodontal care. Fifty patients who voluntarily decide to participate will receive dental scaling associated with two different antibiotics or placebo capsules. Paper points will be used to collect dental plaque samples and levels of bacteria will be determined. Dental specialists will also perform clinical examinations. Patients would be available for 4 dental appointments: prior to and 3, 6 and 12 months after dental scaling.
Detailed description
The benefits of amoxicillin (AMX) plus metronidazole (MTZ) adjunctive to scaling and root planing (SRP) require further investigation, particularly in individuals with a high occurrence of recurrent periodontal pockets under periodontal maintenance therapy (PMT). The aim of the study was to evaluate the clinical and microbiological outcomes of systemic AMX+MTZ adjunctive to SRP in patients with recurring sites [probing depth (PD) ≥5 mm) under PMT, after 1 year of follow-up, compared to SRP alone.
Methods: A randomized controlled clinical trial will be conducted with 50 individuals in a PMT program, which will be randomly allocate in two groups: control group (SRP and placebo; n=24) and test group (SRP and systemic MTZ+AMX; n=23). Participants of the present study will be selected from an open cohort study comprising individuals under a PMT program, who were monitored over 12 years of consecutive recall visits (from August 2009 to April 2023). Periodontal clinical parameters and subgingival biofilm samples will be collected by trained and calibrated examiners at baseline (T1), 3 (T2), 6 (T3) and 12 (T4) months after treatment. Microbiological analyses will be performed at T1, T2 and T4 by real-time quantitative polymerase chain reaction.
The percentage of residual pockets will be listed. Additionally, an overall mean PD value will be calculated for the treated sites initially measuring ≥ 5mm and clinical attachment loss (CAL) ≥ 3mm. Statistical testing for normality with respect to the distribution of study outcomes (clinical parameters) will be performed using the Kolmogorov-Smirnov test. Parametric and non-parametric tests (Chi-squared, Wilcoxon and Friedman tests) will be performed when appropriate. Spearman's correlation (r) will be used to evaluate the relationship between bacterial counts and periodontal condition between groups and evaluation times. All analyses will be performed using statistical software Statistical Package for the Social Sciences (SPSS) (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- After clinical examination, participants will be randomly allocated into two treatment groups: 1) control group (SRP) - systemic administration of placebo after SRP (n = 25); 2) test group (SRP+AMX+MTZ) - systemic administration of AMX+MTZ after SRP (n=25).
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: placebo1) scaling and root planing (SRP) plus systemic administration of placebo (n=25) |
| antibiotics | Experimental | Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams2) scaling and root planing (SRP) plus systemic administration of amoxicillin and metronidazole (n=25). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- individuals under a PMT program
- monitored over ~13 years of consecutive recall visits (from August 2009 to May 2023).
- individuals reclassified as stage III and IV periodontitis
- not having presented the following clinical endpoint in two consecutive PMT visits - presence of ≤4 sites with PD ≥5 mm
- non-diabetics
Key exclusion criteria (5 listed)
- pregnant or lactating women
- smokers
- presence of systemic diseases that could affect the progression of periodontitis long-term administration of anti-inflammatory drugs,
- need for antibiotic premedication for routine dental therapy and
- allergy to metronidazole or amoxicillin
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 |
|---|---|---|
| Amoxicillin 500 milligrams capsules plus metronidazole 400 milligramsAlso: Amoxicillin Trihydrate, Amoxilsupra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of amoxicillin (500 milligrams) + metronidazole (400 milligrams) three times a day for 7 days after SRP | Drug | antibiotics |
| placebosupra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of placebo containing corn starch capsules three times a day for 7 days after SRP | Other | control |
Primary outcome
whole-mouth periodontal pocket depth improvement
Time frame: baseline and 12 months
mean pocket depth (PD) in millimeters
changes in percentage of deep periodontal pocket
Time frame: baseline and 12 months
proportion of sites with PD ≥5 millimeters
2 secondary outcomes
total bacterial load in sub gingival samples
Time frame: baseline and 3 months
levels of target species in sub gingival samples
Time frame: baseline and 3 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 3 Mar 2025.
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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.
Fernando O Costa, PhD principal investigator
Titular Professor in periodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams in people with Periodontitis and Periodontal Pocket, run by Federal University of Minas Gerais 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 7 inclusion and 5 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 3 Mar 2025. 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. 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?
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?
whole-mouth periodontal pocket depth improvement (time frame: baseline and 12 months). The study lists 2 primary outcomes in all. 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 3 Mar 2025.