Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Other: Biorepair Toothpaste + Mousse
* Other: Biorepair Toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial group<br>Biorepair Toothpaste + Mousse domiciliary use | Other: Biorepair Toothpaste + Mousse<br>* Domiciliary application of the products twice a day.<br>|
| Active Comparator: Control group<br>Biorepair Toothpaste domiciliary use. | Other: Biorepair Toothpaste<br>* Domiciliary application of the product twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy