Periodontal Diseases
Conditions
Keywords
pregnancy
Brief summary
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: * Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day * Control group: home oral application of Biorepair Peribioma Toothpaste Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
Detailed description
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: * Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day * Control group: home oral application of Biorepair Peribioma Toothpaste 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.
Interventions
OTHERBiorepair Toothpaste + Mousse
Domiciliary application of the products twice a day.
OTHERBiorepair Toothpaste
Domiciliary application of the product twice a day.
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PPD - Probing Pocket Depth | Baseline, after 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 BOP - Bleeding on Probing (percentage) | Baseline, after 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 CAL - Clinical Attachment Loss | Baseline, after 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 R - Gingival recession | Baseline, after 1, 3 and 6 months. | Distance (in mm) between the gingival margin and the amelo-cemental junction. |
| Change in PCR% - Plaque Control Record | Baseline, after 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 MGI - Modified Gingival Index | Baseline, after 1, 3 and 6 months. | Scoring criteria: * 0: normal * 1: mild inflammation (slight changes in color and texture, but not in all portions of gingival marginal or papillary) * 2: mild inflammation (slight changes in color and texture in all portions of gingival marginal or papillary) * 3: moderate (bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary) * 4: severe inflammation (erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration) |
| Change in PMGI - Papillary Marginal Gingival Index | Baseline, after 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. |
Countries
Italy
Outcome results
None listed