Generalized Aggressive PeriodontitisPhase 4NCT03933501
Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
A Phase 4 study testing amoxicillin and metronidazole in people with Generalized Aggressive Periodontitis, run by University of Campinas, Brazil.
Trial summary
This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Aggressive Periodontitis
- What is being tested?
- amoxicillin and metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 1 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of GAgP;
- presence of 20 teeth;
- presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth with PD>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
- good general health;
- <35 years of age.
Who cannot join
- were pregnant or lactating;
- were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
- received antimicrobials in the previous 3 months;
- were taking long-term anti-inflammatory drugs;
- received a course of periodontal treatment within the last 6 months;
- smoked
About this study
Official title: The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).
Read the detailed description
Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).
- Conditions
- Generalized Aggressive Periodontitis
- Being tested
- amoxicillin and metronidazole, Placebos
- Keywords
- Aggressive periodontitis, anti-infective agents, debridement, randomized clinical trial, ultrasonic
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin and metronidazoleDrug
375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
PlacebosDrug
Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| FMUD + AM | Experimental | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days. Receives: Drug: amoxicillin and metronidazole |
| FMUD | Placebo comparator | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days. Receives: Drug: Placebos |
| SRP + AM | Experimental | Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days. Receives: Drug: amoxicillin and metronidazole |
| SRP | Placebo comparator | Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the baseline relative clinical attachment level at 6 months
distance from the bottom of the pocket to the stent margin.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (3)
Change of the baseline probing depth at 6 months
Distance from the bottom of pocket to gingival margin;
Measured: Baseline, 3 months and 6 months
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
Concentration of IL-1β, IL-10 released in gingival crevicular fluid
Measured: Baseline, 3 months and 6 months
Change in the microbial composition at 6 months
Concentration of bacteria in the subgingival biofilm
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jan 2006
- Primary completion1 Dec 2008
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Aggressive PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933501
- Sponsor's protocol ID
- 06/0024
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.
PubMed 31448837
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
- ClinicalTrials.gov ID
- NCT03933501
- Acronym / sponsor ID
- 06/0024
- Conditions
- Generalized Aggressive Periodontitis
- Keywords
- Aggressive periodontitis, anti-infective agents, debridement, randomized clinical trial, ultrasonic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 1 May 2019 (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 study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).
Detailed description
Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FMUD + AM | Experimental | Drug: amoxicillin and metronidazoleOne session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days. |
| FMUD | Placebo comparator | Drug: PlacebosOne session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days. |
| SRP + AM | Experimental | Drug: amoxicillin and metronidazoleFour sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days. |
| SRP | Placebo comparator | Drug: PlacebosFour sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of GAgP;
- presence of 20 teeth;
- presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth with PD>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
- good general health;
- <35 years of age.
Key exclusion criteria (6 listed)
- were pregnant or lactating;
- were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
- received antimicrobials in the previous 3 months;
- were taking long-term anti-inflammatory drugs;
- received a course of periodontal treatment within the last 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 |
|---|---|---|
| amoxicillin and metronidazole375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days. | Drug | FMUD + AM, SRP + AM |
| PlacebosTwo distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days. | Drug | FMUD, SRP |
Primary outcome
Change of the baseline relative clinical attachment level at 6 months
Time frame: Baseline, 3 months and 6 months
distance from the bottom of the pocket to the stent margin.
3 secondary outcomes
Change of the baseline probing depth at 6 months
Time frame: Baseline, 3 months and 6 months
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
Time frame: Baseline, 3 months and 6 months
Change in the microbial composition at 6 months
Time frame: Baseline, 3 months and 6 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 13 May 2019.
- Derived from this study: PubMed 31448837Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin and metronidazole in people with Generalized Aggressive Periodontitis, run by University of Campinas, 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 5 inclusion and 6 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Change of the baseline relative clinical attachment level at 6 months (time frame: Baseline, 3 months and 6 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 NCT03933501, which also lists 1 linked publication.
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 May 2019.