Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
NCT ID: NCT05400538
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-06-10
2023-10-20
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trial group
Biorepair Toothpaste + Mousse domiciliary use
Biorepair Toothpaste + Mousse
Domiciliary application of the products twice a day.
Control group
Biorepair Toothpaste domiciliary use.
Biorepair Toothpaste
Domiciliary application of the product twice a day.
Interventions
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Biorepair Toothpaste + Mousse
Domiciliary application of the products twice a day.
Biorepair Toothpaste
Domiciliary application of the product twice a day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
35 Years
FEMALE
Yes
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2022-PREGNANCY
Identifier Type: -
Identifier Source: org_study_id