Emoform Glic Toothpaste: Daily use of Emoform Glic toothpaste twice a day during home oral hygiene
Emoform Glic Mouthwash: Daily use of Emoform Glic mouthwash twice a day during home oral hygiene
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria:
* women at the 4th month of pregnancy
Exclusion Criteria:
* presence of cardiac pacemaker
* neurological and psychiatric diseases
* patients taking bisphosphonates during the previous 12 months from the - beginning of the study
* patients undergoing anticancer therapy.
* patients with poor compliance.
Primary outcome measure(s)
Change in Recession (R) — Baseline, 1, 3 and 6 months Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in Plaque Index (Silness and Loe, 1964) — 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 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 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
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 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 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).
Trial sites (1)
Facility
City
Region
Status
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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