Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

The primary outcome of this study is the change in dental plaque levels assessed using the Plaque Index (PI) developed by Silness and Löe. This index measures the thickness of dental plaque at the gingival margin. For each participant, four surfaces of each tooth (buccal, lingual, mesial, and distal) are examined and scored on a scale from 0 to 3. A score of 0 corresponds to the absence of plaque. A score of 1 indicates the presence of a plaque film only visible with a disclosing agent or by using a periodontal probe. A score of 2 indicates visible moderate plaque accumulation at the gingival margin, while a score of 3 reflects heavy plaque deposits within the gingival sulcus and around the gingival margin. The final PI for each subject is obtained by calculating the mean of all recorded surface scores. This measure provides a continuous variable where higher scores represent greater plaque accumulation and worse oral hygiene. The index will be recorded at four time points: baseline (

This outcome assesses the degree of gingival inflammation by measuring the percentage of sites exhibiting bleeding after gentle probing of the gingival sulcus using a calibrated periodontal probe. BoP is recorded dichotomously, assigning a score of 0 to non-bleeding sites and 1 to bleeding sites. The final BoP score is calculated as the proportion of bleeding sites over the total number of examined sites, expressed as a percentage. Higher percentages indicate more severe inflammation. BoP values will be collected at baseline and at 1, 3, and 6 months to compare the anti-inflammatory effectiveness of the two home care protocols.

This outcome measures the depth of the gingival sulcus or periodontal pocket using a periodontal probe. Probing Pocket Depth (PPD) is defined as the distance, in millimeters, from the free gingival margin to the bottom of the sulcus or pocket. Six sites per tooth are examined, and the average depth per participant is calculated. Deeper pockets reflect more severe periodontal involvement. PPD scores will be compared between the experimental and control groups at baseline, 1, 3, and 6 months to evaluate the effect of the lactoferrin-based mouthwash in addition to toothpaste.

Clinical Attachment Level (CAL) represents the cumulative loss of periodontal supporting tissue and is calculated as the distance from the cementoenamel junction (CEJ) to the base of the sulcus or periodontal pocket. It is measured in millimeters at six sites per tooth using a calibrated probe. Improvements in CAL over time reflect periodontal healing or stabilization.

The Modified Gingival Index (MGI) is a non-invasive visual index that evaluates gingival inflammation based on changes in color, consistency, and swelling of the marginal tissues. Scores range from 0 (normal, healthy gingiva) to 4 (severe inflammation with spontaneous bleeding). It does not require probing. The mean score per patient is used to assess the effectiveness of treatment.

The Approximal Plaque Index (API) quantifies dental plaque located on interproximal surfaces. After applying a disclosing agent, the presence or absence of plaque is visually evaluated on approximal areas. The score is calculated as the percentage of plaque-positive sites over the total number of interproximal sites examined. Lower values indicate better interproximal hygiene.

The Plaque Control Record (PCR%) provides an overview of plaque presence across all four surfaces (buccal, lingual, mesial, distal) of each tooth. After staining with a plaque disclosing agent, the number of plaque-positive surfaces is recorded and divided by the total number of surfaces examined, expressed as a percentage. This index is used to monitor the effectiveness of plaque control strategies.

The Papillary-Marginal-Gingival Index (PMGI) assesses inflammation specifically in the interdental papilla and marginal gingiva through visual inspection. Scores range from 0 (normal appearance) to 5 (severe inflammation with ulceration and spontaneous bleeding). This score allows detection of early localized inflammatory changes not always reflected in broader indices.

Gingival Recession (R) is defined as the apical migration of the gingival margin with respect to the cementoenamel junction (CEJ), measured in millimeters. It reflects soft tissue loss and root exposure. Clinical measurements are used to monitor whether the intervention prevents further recession or contributes to soft tissue stabilization.