Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women

Condition(s) studied

Investigational drug(s) / intervention(s)

Probiotic 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®)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Plaque Index — Baseline, 1, 3 and 6 months
  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.
• Change in Recession (R) — Baseline, 1, 3 and 6 months
  Distance (in mm) between the gingival margin and the amelo-cemental junction.
• Change in Clinical Attachment Loss (CAL) — Baseline, 1, 3 and 6 months
  Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
• Change in Bleeding on Probing (BoP) — Baseline, 1, 3 and 6 months
  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%.
• Change in Probing Pocket Depth (PPD) — Baseline, 1, 3 and 6 months
  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.
• Change in API - Approximal Plaque Index — Baseline, 1, 3 and 6 months
  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).
• Change in Plaque Control Record (PCR%) — Baseline, 1, 3 and 6 months
  % 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.
• Change in Papillary Marginal Gingival Index (PMGI) — Baseline, 1, 3 and 6 months
  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.
• Change in modified Marginal Gingival Index (mMGI) — Baseline, 1, 3 and 6 months
  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

Trial sites (1)

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