Chronic Periodontitis, GeneralizedNCT05734274
Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
A study testing Probiotics in people with Chronic Periodontitis, Generalized, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis, Generalized
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2023to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old, who intend to voluntarily participate in the study and:
- Have a definitive diagnosis of stage II, grade A, B or C, generalized periodontitis (2018, World Workshop);
- Have at least 3 natural teeth maintained per quadrant.
Who cannot join
- • Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;
- Patients who have received any type of periodontal treatment 2 months prior to the start of study participation;
- Pregnant or breastfeeding patients;
- Patients with associated systemic pathology, such as diabetes, HIV, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants;
- Patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-A and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride);
- Patients undergoing anticoagulant therapy;
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- Patients allergic to both lidocaine, articaine and mepivacaine;
- Patients who require antibiotic prophylaxis for bacterial endocarditis;
- Patients who have had antibiotic therapy within 2 months of study participation;
- Patients using chlorhexidine, or other mouthwashes or elixirs;
- Patients undergoing orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine - University of Porto
Porto, 4200-393
André Marques, MDent, +351965074955, andrecnbmarques@hotmail.com
About this study
Official title: Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis.
Read the detailed description
The main purpose of this study is to assess the effect on disease progression of the probiotic Limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage II, grade A, B and C, generalized periodontitis: evaluated by Bleeding on Probing (BoP) - Lindhe, 1972. The secondary purpose is to evaluate the effect of this probiotic on the values of Plaque Index (PI) - Silness \& Löe, 1964; Gingival Index (GI) - Löe \& Silness, 1963; Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) - Ramfjord, 1959, when compared to a negative control product.
- Conditions
- Chronic Periodontitis, Generalized
- Being tested
- Probiotics, Negative control
- Keywords
- probiotics, Limosilactobacillus reuteri
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Negative controlOther
Sugar-free negative control lozenges.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Lozenge | Experimental | Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. Receives: Other: Probiotics |
| Negative control Lozenge | Sham comparator | Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Bleeding on probing (in percentage) will be assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively.
Measured: 0, 21, 90, 180 days
Secondary outcomes (4)
Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964
Each of the four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) is given a score from 0-3; this is the Pl for the area (using plaque discloser. The scores from the four areas of the tooth may be added and divided by four to give the Pl for the tooth. Finally, by adding the indices for the teeth and dividing by the number of teeth examined, the Pl for the individual is obtained.
Scores criteria:
0 Absence of microbial plaque.
- Thin film of microbial plaque along the free gingival margin.
- Moderate accumulation with plaque in the sulcus.
- Large amount of plaque in sulcus or pocket along the free gingiva margin.
Measured: 0, 21, 90, 180 days
Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963
Four gingival areas of the tooth (mesialbuccal, buccal, distobuccal and palatinal/lingual) are given a score from 0 to 3; this is the Gl for the area. The scores from the four areas of the tooth may be added and divided by four to give the GI for the tooth. Finally, by adding the indices for the teeth and dividing by the total number of teeth examined, the Gl for the individual is obtained. The index for the subject is thus an average score for the areas examined.
Scores criteria:
0 Normal gingiva: Natural coral pink gingival with no e/o inflammation.
- Mild inflammation: Slight changes in color, slight edema. No bleeding on probing.
- Moderate inflammation: Redness, edema and glazing. Bleeding upon probing.
- Severe inflammation: Marked redness and edema/ulceration/tendency to bleed spontaneously.
Measured: 0, 21, 90, 180 days
Change From Baseline in Probing Depth (PD)
The distance measured from the base of the sulcus or pocket to the free gingival margin.
Measured: 0, 21, 90, 180 days
Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959
It is calculated by adding the Probing Pocket Depth to the distance between the cementoenamel junction and the gingival margin (if it is a recession, the value is positive, if it is an increase in gingival volume the recorded value is negative).
Measured: 0, 21, 90, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Periodontitis, GeneralizedStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marques, Universidade do Porto
- Investigators
- André Marques, MDent, Principal investigator, Estudante da Especialização de Periodontologia e Implantologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734274
- Sponsor's protocol ID
- 31/2021
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei SH, Lang NP. Periodontal epidemiological indices for children and adolescents: II. Evaluation of oral hygiene; III. Clinical applications. Pediatr Dent. 1982 Mar;4(1):64-73. No abstract available.
PubMed 6960328Montero E, Iniesta M, Rodrigo M, Marin MJ, Figuero E, Herrera D, Sanz M. Clinical and microbiological effects of the adjunctive use of probiotics in the treatment of gingivitis: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):708-716. doi: 10.1111/jcpe.12752. Epub 2017 Jun 23.
PubMed 28556062Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13.
PubMed 22694350Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344.
PubMed 21523225Song D, Liu XR. Role of probiotics containing Lactobacillus reuteri in adjunct to scaling and root planing for management of patients with chronic periodontitis: a meta-analysis. Eur Rev Med Pharmacol Sci. 2020 Apr;24(8):4495-4505. doi: 10.26355/eurrev_202004_21032.
PubMed 32373987Tekce M, Ince G, Gursoy H, Dirikan Ipci S, Cakar G, Kadir T, Yilmaz S. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol. 2015 Apr;42(4):363-72. doi: 10.1111/jcpe.12387. Epub 2015 Apr 10.
PubMed 25728888
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05734274
- Acronym / sponsor ID
- 31/2021
- Conditions
- Chronic Periodontitis, Generalized
- Keywords
- probiotics, Limosilactobacillus reuteri
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 17 Feb 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.
The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis.
Detailed description
The main purpose of this study is to assess the effect on disease progression of the probiotic Limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage II, grade A, B and C, generalized periodontitis: evaluated by Bleeding on Probing (BoP) - Lindhe, 1972. The secondary purpose is to evaluate the effect of this probiotic on the values of Plaque Index (PI) - Silness \& Löe, 1964; Gingival Index (GI) - Löe \& Silness, 1963; Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) - Ramfjord, 1959, when compared to a negative control product.
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 |
|---|---|---|
| Probiotics Lozenge | Experimental | Other: ProbioticsSubjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. |
| Negative control Lozenge | Sham comparator | Other: Negative controlSubjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old, who intend to voluntarily participate in the study and:
Key exclusion criteria (11 listed)
- • Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;
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 |
|---|---|---|
| ProbioticsProbiotics lozenge containing at least 200 million active Limosilactobacillus reuteri. | Other | Probiotics Lozenge |
| Negative controlSugar-free negative control lozenges. | Other | Negative control Lozenge |
Primary outcome
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Time frame: 0, 21, 90, 180 days
Bleeding on probing (in percentage) will be assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively.
4 secondary outcomes
Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964
Time frame: 0, 21, 90, 180 days
Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963
Time frame: 0, 21, 90, 180 days
Change From Baseline in Probing Depth (PD)
Time frame: 0, 21, 90, 180 days
Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959
Time frame: 0, 21, 90, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 6960328Wei SH, Lang NP. Periodontal epidemiological indices for children and adolescents: II. Evaluation of oral hygiene; III. Clinical applications. Pediatr Dent. 1982 Mar;4(1):64-73. No abstract available.
- Background: PubMed 28556062Montero E, Iniesta M, Rodrigo M, Marin MJ, Figuero E, Herrera D, Sanz M. Clinical and microbiological effects of the adjunctive use of probiotics in the treatment of gingivitis: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):708-716. doi: 10.1111/jcpe.12752. Epub 2017 Jun 23.
- Background: PubMed 22694350Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13.
- Background: PubMed 21523225Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344.
- Background: PubMed 32373987Song D, Liu XR. Role of probiotics containing Lactobacillus reuteri in adjunct to scaling and root planing for management of patients with chronic periodontitis: a meta-analysis. Eur Rev Med Pharmacol Sci. 2020 Apr;24(8):4495-4505. doi: 10.26355/eurrev_202004_21032.
- Background: PubMed 25728888Tekce M, Ince G, Gursoy H, Dirikan Ipci S, Cakar G, Kadir T, Yilmaz S. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol. 2015 Apr;42(4):363-72. doi: 10.1111/jcpe.12387. Epub 2015 Apr 10.
- Individual participant dataSharing planned: No
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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.
André Marques, MDent principal investigator
Estudante da Especialização de Periodontologia e Implantologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Chronic Periodontitis, Generalized, run by Universidade do Porto at 1 site in Portugal.
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 3 inclusion and 11 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 28 Nov 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Marques, MDent (+351965074955, andrecnbmarques@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972 (time frame: 0, 21, 90, 180 days). 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 NCT05734274, which also lists 6 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 28 Nov 2023.