Clinical trial NCT05400538: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: pregnancy
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in PPD - Probing Pocket Depth
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in CAL - Clinical Attachment Loss
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in R - Gingival recession
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in PCR% - Plaque Control Record
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in MGI - Modified Gingival Index
timeFrame: Baseline, after 1, 3 and 6 months.
measure: Change in PMGI - Papillary Marginal Gingival Index
timeFrame: Baseline, after 1, 3 and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: