The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.
The aim of the study is to assess the effect of lactoferrin in LBC complex 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: \- the Trial group, in which patients will perform home oral hygiene with Emoform Glic toothpaste + mouthwash twice a day the Control group, in which patients will perform home oral hygiene with Emoform Glic toothpaste twice a day. Professional debridement will be repeated every 3 months. Periodontal indexes evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Daily use of Emoform Glic toothpaste twice a day during home oral hygiene
Daily use of Emoform Glic mouthwash twice a day during home oral hygiene
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
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 Plaque Index (Silness and Loe, 1964)
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 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 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
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.
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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 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