Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis

Chronic Periodontitis, Generalized Clinical Trial

Official title:

Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734274
• Other study ID #: 31/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Universidade do Porto
• Contact: André Marques, MDent
• Phone: +351965074955
• Email: andrecnbmarques[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis, Generalized
• Periodontitis

Intervention

Other:
• Probiotics
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
• Negative control
Sugar-free negative control lozenges.

Locations

Country	Name	City	State
Portugal	Faculty of Dental Medicine - University of Porto	Oporto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 21, 90, 180 days
Secondary	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.	0, 21, 90, 180 days
Secondary	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.	0, 21, 90, 180 days
Secondary	Change From Baseline in Probing Depth (PD)	The distance measured from the base of the sulcus or pocket to the free gingival margin.	0, 21, 90, 180 days
Secondary	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).	0, 21, 90, 180 days