Back to resultsClinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
Primary Purpose
Chronic Periodontitis, Generalized
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Probiotics
Negative control
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis, Generalized focused on measuring probiotics, Limosilactobacillus reuteri
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: • 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; 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.
Sites / Locations
- Faculty of Dental Medicine - University of PortoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Probiotics Lozenge
Negative control Lozenge
Arm Description
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change From Baseline in Probing Depth (PD)
The distance measured from the base of the sulcus or pocket to the free gingival margin.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05734274
Brief Title
Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
Official Title
Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Generalized
Keywords
probiotics, Limosilactobacillus reuteri
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics Lozenge
Arm Type
Experimental
Arm Description
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Arm Title
Negative control Lozenge
Arm Type
Sham Comparator
Arm Description
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Intervention Type
Other
Intervention Name(s)
Probiotics
Intervention Description
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Intervention Type
Other
Intervention Name(s)
Negative control
Intervention Description
Sugar-free negative control lozenges.
Primary Outcome Measure Information:
Title
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
Description
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.
Time Frame
0, 21, 90, 180 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964
Description
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.
Time Frame
0, 21, 90, 180 days
Title
Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963
Description
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.
Time Frame
0, 21, 90, 180 days
Title
Change From Baseline in Probing Depth (PD)
Description
The distance measured from the base of the sulcus or pocket to the free gingival margin.
Time Frame
0, 21, 90, 180 days
Title
Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959
Description
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).
Time Frame
0, 21, 90, 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
• 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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André Marques, MDent
Phone
+351965074955
Email
andrecnbmarques@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Marques, MDent
Organizational Affiliation
Estudante da Especialização de Periodontologia e Implantologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dental Medicine - University of Porto
City
Oporto
ZIP/Postal Code
4200-393
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Marques, MDent
Phone
+351965074955
Email
andrecnbmarques@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6960328
Citation
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.
Results Reference
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PubMed Identifier
28556062
Citation
Montero 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.
Results Reference
background
PubMed Identifier
22694350
Citation
Iniesta 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.
Results Reference
background
PubMed Identifier
21523225
Citation
Vivekananda 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.
Results Reference
background
PubMed Identifier
32373987
Citation
Song 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.
Results Reference
background
PubMed Identifier
25728888
Citation
Tekce 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.
Results Reference
background
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Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis
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