Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group | Experimental | Biorepair Toothpaste + Mousse domiciliary use |
|
| Control group | Active Comparator | Biorepair Toothpaste domiciliary use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepair Toothpaste + Mousse | Other | Domiciliary application of the products twice a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PPD - Probing Pocket Depth | 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. | Baseline, after 1, 3 and 6 months. |
| Change in BOP - Bleeding on Probing (percentage) | 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%. | Baseline, after 1, 3 and 6 months. |
| Change in CAL - Clinical Attachment Loss | Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ). | Baseline, after 1, 3 and 6 months. |
| Change in R - Gingival recession | Distance (in mm) between the gingival margin and the amelo-cemental junction. | Baseline, after 1, 3 and 6 months. |
| Change in PCR% - Plaque Control Record | % 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. | Baseline, after 1, 3 and 6 months. |
| Change in MGI - Modified Gingival Index | Scoring criteria:
|
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD, MS | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to the Principal Investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biorepair Toothpaste |
| Other |
Domiciliary application of the product twice a day. |
|
| Baseline, after 1, 3 and 6 months. |
| Change in PMGI - Papillary Marginal Gingival Index | 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. | Baseline, after 1, 3 and 6 months. |