-Chronic PeriodontitisPhase 2probioticNCT02283736

Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

A Phase 2 study testing Lactobacillus rhamnosus SP1, Talc powder and Periodontal treatment in people with -Chronic Periodontitis, run by Jorge Gamonal at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic 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, Talc powder and Periodontal treatment
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: 36 participants
Where: 1 siteChile
Study dates: Jun 2014to Dec 2016
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

Other trials in Chile

About this study

Official title: Efficacy of Oral Probiotic 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 as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

Conditions: -Chronic Periodontitis
Being tested: Lactobacillus rhamnosus SP1, Talc powder, Periodontal treatment
Keywords: Chronic periodontitis, Probiotics, Non- surgical treatment
Medical subject headings: Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lactobacillus rhamnosus SP1Other
Tablet containing Lactobacillus rhamnosus SP1
Talc powderOther
Tablet containing talc powder
Periodontal treatmentProcedure or surgery
Scaling and root planning

Study groups in NCT02283736
Study group	Role	What they receive
Periodontal treatment, Probitic	Experimental	Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months. Receives: Other: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment
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

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 months

Secondary outcomes (5)

Differences between groups for probing depth changes
Measured: baseline, 3, 6 month
Differences between groups for bleeding on probing changes
Measured: baseline, 3, 6 months
Differences between groups for plaque index changes
Measured: baseline, 3, 6 months
Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid
Measured: baseline, 3, 6 months
Differences between groups for levels of periodontal pathogens changes
Measured: baseline, 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Dec 2016

First posted5 Nov 2014 (estimated)
Study startJun 2014
Primary completionJun 2015
Study completionDec 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02283736
Sponsor's protocol ID: FONDECYT 1130570
Acronym: probiotic
Status last verified: Jun 2016
First submitted: 1 Nov 2014
Last updated: 15 Jun 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

All -Chronic Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.
ClinicalTrials.gov ID: NCT02283736
Acronym / sponsor ID: probiotic / FONDECYT 1130570
Conditions: -Chronic Periodontitis
Keywords: Chronic periodontitis, Probiotics, Non- surgical treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (actual)
Lead sponsor: Jorge GamonalUniversity, hospital or other
Study start: Jun 2014
Primary completion: Jun 2015 (actual)
Study completion: Dec 2016 (estimated)
First posted: 5 Nov 2014 (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 as an adjunct to scaling and root planning (SRP).

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
Periodontal treatment, Probitic	Experimental	Other: Lactobacillus rhamnosus SP1, Procedure: Periodontal treatmentPeriodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Periodontal treatment, talc powder tab	Placebo comparator	Other: Talc powder, Procedure: Periodontal treatmentPeriodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 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

Key exclusion criteria (4 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 SP1Tablet containing Lactobacillus rhamnosus SP1	Other	Periodontal treatment, Probitic
Talc powderTablet containing talc powder	Other	Periodontal treatment, talc powder tab
Periodontal treatmentScaling and root planning	Procedure or surgery	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 months

5 secondary outcomes

Differences between groups for probing depth changes
Time frame: baseline, 3, 6 month
Differences between groups for bleeding on probing changes
Time frame: baseline, 3, 6 months
Differences between groups for plaque index changes
Time frame: baseline, 3, 6 months
Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid
Time frame: baseline, 3, 6 months
Differences between groups for levels of periodontal pathogens changes
Time frame: baseline, 3, 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.

Related trials for -Chronic Periodontitis

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

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.

Jorge Gamonal, Professor principal investigator

Faculty of Dentistry of University of Chile

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, Talc powder and Periodontal treatment in people with -Chronic Periodontitis, run by Jorge Gamonal 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 6 inclusion and 4 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 15 Jun 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 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 NCT02283736.

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 15 Jun 2016.