Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
Primary Purpose
Periodontal Diseases
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biorepair Toothpaste + Mousse
Biorepair Toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring pregnancy
Eligibility Criteria
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.
Sites / Locations
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial group
Control group
Arm Description
Biorepair Toothpaste + Mousse domiciliary use
Biorepair Toothpaste domiciliary use.
Outcomes
Primary Outcome Measures
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.
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%.
Change in CAL - Clinical Attachment Loss
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
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.
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400538
Brief Title
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
Official Title
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial group
Arm Type
Experimental
Arm Description
Biorepair Toothpaste + Mousse domiciliary use
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Biorepair Toothpaste domiciliary use.
Intervention Type
Other
Intervention Name(s)
Biorepair Toothpaste + Mousse
Intervention Description
Domiciliary application of the products twice a day.
Intervention Type
Other
Intervention Name(s)
Biorepair Toothpaste
Intervention Description
Domiciliary application of the product twice a day.
Primary Outcome Measure Information:
Title
Change in PPD - Probing Pocket Depth
Description
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, after 1, 3 and 6 months.
Title
Change in BOP - Bleeding on Probing (percentage)
Description
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, after 1, 3 and 6 months.
Title
Change in CAL - Clinical Attachment Loss
Description
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Time Frame
Baseline, after 1, 3 and 6 months.
Title
Change in R - Gingival recession
Description
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Time Frame
Baseline, after 1, 3 and 6 months.
Title
Change in PCR% - Plaque Control Record
Description
% 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, after 1, 3 and 6 months.
Title
Change in MGI - Modified Gingival Index
Description
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)
Time Frame
Baseline, after 1, 3 and 6 months.
Title
Change in PMGI - Papillary Marginal Gingival Index
Description
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.
Time Frame
Baseline, after 1, 3 and 6 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD, MS
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to the Principal Investigator.
Learn more about this trial
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
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