Aggressive PeriodontitisNCT02829983
Clarithromycin as Adjuvant to Periodontal Debridement
A study testing Clarithromycin and One-stage full-mouth ultrasonic debridement (FMUD) in people with Aggressive Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- Clarithromycin and One-stage full-mouth ultrasonic debridement (FMUD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of Generalized Aggressive Periodontitis
- presence of ≥20 teeth
- presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites 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
- agree to participate in the study and sign a written consent
Who cannot join
- pregnant or lactating
- suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- received antimicrobials in the previous 6 months
- taking long-term anti-inflammatory drugs
- received a course of periodontal treatment within the last 12 months
- smoked
About this study
Official title: Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.
Read the detailed description
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
- Conditions
- Aggressive Periodontitis
- Being tested
- Clarithromycin, Placebo, One-stage full-mouth ultrasonic debridement (FMUD)
- Keywords
- clarithromycin, periodontal debridement, aggressive periodontitis
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Also called macrolide
Use of 500mg of Clarithromycin twice a day for 3 days
PlaceboDrug
Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD)Other
One session of Periodontal debridement using ultrasonic device.
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin group | Active comparator | 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Receives: Drug: Clarithromycin; Other: One-stage full-mouth ultrasonic debridement (FMUD) |
| placebo group | Placebo comparator | 20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Receives: Drug: Placebo; Other: One-stage full-mouth ultrasonic debridement (FMUD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
Distance from bottom of pocket to the cement-enamel junction (CEJ).
Measured: 6 months
Secondary outcomes (1)
Probing Depth
Distance from the bottom of sulcus/pocket to gingival margin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, DDS, PhD, Study director, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829983
- Sponsor's protocol ID
- NMRBA
- Status last verified
- Oct 2017
- First submitted
- 8 Jul 2016
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided
Publications
Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Goncalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.
PubMed 22288485Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.
PubMed 34790237Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
PubMed 33197289Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3.
PubMed 28671507
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02829983
- Acronym / sponsor ID
- NMRBA
- Conditions
- Aggressive Periodontitis
- Keywords
- clarithromycin, periodontal debridement, aggressive periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 17 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.
Detailed description
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clarithromycin group | Active comparator | Drug: Clarithromycin, Other: One-stage full-mouth ultrasonic debridement (FMUD)20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. |
| placebo group | Placebo comparator | Drug: Placebo, Other: One-stage full-mouth ultrasonic debridement (FMUD)20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosis of Generalized Aggressive Periodontitis
- presence of ≥20 teeth
- presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites 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)
- pregnant or lactating
- suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- received antimicrobials in the previous 6 months
- taking long-term anti-inflammatory drugs
- received a course of periodontal treatment within the last 12 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 |
|---|---|---|
| ClarithromycinAlso: macrolideUse of 500mg of Clarithromycin twice a day for 3 days | Drug | clarithromycin group |
| PlaceboUse of placebo tablets twice a day for 3 days. | Drug | placebo group |
| One-stage full-mouth ultrasonic debridement (FMUD)One session of Periodontal debridement using ultrasonic device. | Other | clarithromycin group, placebo group |
Primary outcome
Clinical Attachment Level
Time frame: 6 months
Distance from bottom of pocket to the cement-enamel junction (CEJ).
1 secondary outcome
Probing Depth
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22288485Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Goncalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.
- Derived from this study: PubMed 34790237Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.
- Derived from this study: PubMed 33197289Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
- Derived from this study: PubMed 28671507Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Mauro P Santamaria, DDS, PhD study director
UPECLIN HC FM Botucatu Unesp
Questions about this trial
What is this clinical trial studying?
A study testing Clarithromycin and One-stage full-mouth ultrasonic debridement (FMUD) in people with Aggressive Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 6 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 21 Nov 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Attachment Level (time frame: 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 NCT02829983, which also lists 4 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 21 Nov 2017.