An interventional study of Probiotics and Negative control in Chronic Periodontitis, Generalized, sponsored by Universidade do Porto. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 years old, who intend to voluntarily participate in the study and:
Exclusion Criteria:
Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Other: Probiotics
Subjects are instructed to take a lozenge twice a day, after brushing, in the morning and the evening.
Other: Negative control
Probiotics lozenge containing at least 200 million active Limosilactobacillus reuteri.
Sugar-free negative control lozenges.
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.
Time frame: 0, 21, 90, 180 days
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. 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.
Time frame: 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. 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.
Time frame: 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.
Time frame: 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).
Time frame: 0, 21, 90, 180 days
Plan to share: No
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Universidade do Porto