An interventional study of Probiotic Treatment and Standard Treatment in Periodontal Diseases and Pregnancy Related, sponsored by University of Pavia. Enrolling by invitation at 1 site in Italy. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.
The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.
At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).
Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.
Subsequently, patients will be randomly divided into two groups:
Professional debridement will be repeated every 3 months. Periodontal index evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).
855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 546 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →University of Pavia is the lead sponsor of 144 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Patients within this group will undergo probiotic supplementation in addition to standard treatment
Other: Probiotic Treatment
Patients within this group will undergo standard treatment
Other: Standard Treatment
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day Probiotic supplementation with daily assumption of Limosilactobacillus Reuteri Prodentis® tablet (PerioBalance, Gum®)
Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day
Change in Plaque Index
Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Time frame: Baseline, 1, 3 and 6 months
Change in Recession (R)
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Time frame: Baseline, 1, 3 and 6 months
Change in Clinical Attachment Loss (CAL)
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Time frame: Baseline, 1, 3 and 6 months
Change in Bleeding on Probing (BoP)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%.
Time frame: Baseline, 1, 3 and 6 months
Change in Probing Pocket Depth (PPD)
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Time frame: Baseline, 1, 3 and 6 months
Change in API - Approximal Plaque Index
Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3).
Time frame: Baseline, 1, 3 and 6 months
Change in Plaque Control Record (PCR%)
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Time frame: Baseline, 1, 3 and 6 months
Change in Papillary Marginal Gingival Index (PMGI)
Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
Time frame: Baseline, 1, 3 and 6 months
Change in modified Marginal Gingival Index (mMGI)
Scoring criteria: 0 = Absence of inflammation 1. = Mild inflammation (marginal or papillary unit) 2. = Mild inflammation (entire marginal and papillary unit) 3. = Moderate inflammation 4. = Severe inflammation
Time frame: Baseline, 1, 3 and 6 months
Plan to share: No — Data will be available upon motivated request to the Principal Investigator.
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