Chronic PeriodontitisPhase 2NCT02839408
Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis
A Phase 2 study testing Lactobacillus rhamnosus SP1, Azithromycin and Talc powder in people with Chronic Periodontitis, run by University of Chile at 1 site in Chile.
Trial summary
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP). 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?
- Lactobacillus rhamnosus SP1, Azithromycin and Talc powder
- 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
- 54 participants
- Where
- 1 siteChile
- Study dates
- Jun 2015to Mar 2017
- Phase
- Phase 2
- 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
- 14 natural teeth, excluding third molars
- 10 posterior teeth
- 35 years old
- 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically
Who cannot join
- Periodontal treatment before the time of examination
- Systemic illness
- Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
Trial locations and contacts
1 site in 1 country.
Chile1 site
Faculty of Dentistry of University of Chile
Santiago, Santiago Metropolitan
About this study
Official title: Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP).
Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.
- Conditions
- Chronic Periodontitis
- Being tested
- Lactobacillus rhamnosus SP1, Azithromycin, Talc powder, Periodontal treatment Scaling and root planning
- Keywords
- periodontitis, azithromycin, probiotic
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus SP1Dietary supplement
Sachet containing Lactobacillus rhamnosus SP1
AzithromycinDrug
Tablet containing 500mg Azithromicyn
Talc powderOther
Sachet containing talc powder and tablet containing talc powder
Periodontal treatment Scaling and root planningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodontal treatment, talc powder tab | Placebo comparator | Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months Receives: Other: Talc powder; Procedure: Periodontal treatment Scaling and root planning |
| Periodontal treatment, Probitic | Experimental | Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months. Receives: Dietary Supplement: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment Scaling and root planning |
| Periodontal treatment, Antibiotic | Experimental | Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin Receives: Drug: Azithromycin; Procedure: Periodontal treatment Scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of at least 1mm between groups for clinical attachment level changes
Measured: baseline, 3, 6, 9 and 12 month
Secondary outcomes (5)
Differences between groups for probing depth changes
Measured: baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes
Measured: baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes
Measured: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
Measured: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes
Measured: baseline, 3, 6, 9 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Gamonal, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839408
- Sponsor's protocol ID
- FONDECYT 1130570.b
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
PubMed 33413320
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT02839408
- Acronym / sponsor ID
- FONDECYT 1130570.b
- Conditions
- Chronic Periodontitis
- Keywords
- periodontitis, azithromycin, probiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 21 Jul 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 randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP).
Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment, talc powder tab | Placebo comparator | Other: Talc powder, Procedure: Periodontal treatment Scaling and root planningPeriodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months |
| Periodontal treatment, Probitic | Experimental | Dietary Supplement: Lactobacillus rhamnosus SP1, Procedure: Periodontal treatment Scaling and root planningPeriodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months. |
| Periodontal treatment, Antibiotic | Experimental | Drug: Azithromycin, Procedure: Periodontal treatment Scaling and root planningPeriodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 14 natural teeth, excluding third molars
- 10 posterior teeth
- 35 years old
- 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically
Key exclusion criteria (3 listed)
- Periodontal treatment before the time of examination
- Systemic illness
- Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
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 |
|---|---|---|
| Lactobacillus rhamnosus SP1Sachet containing Lactobacillus rhamnosus SP1 | Dietary supplement | Periodontal treatment, Probitic |
| AzithromycinTablet containing 500mg Azithromicyn | Drug | Periodontal treatment, Antibiotic |
| Talc powderSachet containing talc powder and tablet containing talc powder | Other | Periodontal treatment, talc powder tab |
| Periodontal treatment Scaling and root planning | Procedure or surgery | Periodontal treatment, Antibiotic, Periodontal treatment, Probitic, Periodontal treatment, talc powder tab |
Primary outcome
Differences of at least 1mm between groups for clinical attachment level changes
Time frame: baseline, 3, 6, 9 and 12 month
5 secondary outcomes
Differences between groups for probing depth changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
Time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes
Time frame: baseline, 3, 6, 9 and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 33413320Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
- Individual participant dataSharing planned: 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus rhamnosus SP1, Azithromycin and Talc powder in people with Chronic Periodontitis, run by University of Chile at 1 site in Chile.
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 3 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 27 Sep 2016. 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 Chile. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Differences of at least 1mm between groups for clinical attachment level changes (time frame: baseline, 3, 6, 9 and 12 month). 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 NCT02839408, 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 27 Sep 2016.