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

Not Applicable

Recruiting

• Conditions: Chronic Periodontitis, Generalized
• Interventions: Other: Negative control; Other: Probiotics

• Registration Number: NCT05734274
• Lead Sponsor: Universidade do Porto

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.

Study Timeline

• Study First Submitted: 2023-01-25
• Study Start: 2023-02-01
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-01
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative control Lozenge	Negative control	Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Probiotics Lozenge	Probiotics	Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963	0, 21, 90, 180 days	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.; 1. Mild inflammation: Slight changes in color, slight edema. No bleeding on probing.; 2. Moderate inflammation: Redness, edema and glazing. Bleeding upon probing.; 3. Severe inflammation: Marked redness and edema/ulceration/tendency to bleed spontaneously.
Change From Baseline in Probing Depth (PD)	0, 21, 90, 180 days	The distance measured from the base of the sulcus or pocket to the free gingival margin.
Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964	0, 21, 90, 180 days	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.; 1. Thin film of microbial plaque along the free gingival margin.; 2. Moderate accumulation with plaque in the sulcus.; 3. Large amount of plaque in sulcus or pocket along the free gingiva margin.
Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959	0, 21, 90, 180 days	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).

Trial Locations

Locations (1)

Faculty of Dental Medicine - University of Porto; 🇵🇹 Oporto, Portugal