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

U

University of Pavia

Status

Completed

Conditions

Periodontal Diseases

Treatments

Other: Biorepair Toothpaste + Mousse
Other: Biorepair Toothpaste

Study type

Interventional

Funder types

Other

Identifiers

NCT05400538
2022-PREGNANCY

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

Trial group
Experimental group
Description:
Biorepair Toothpaste + Mousse domiciliary use
Treatment:
Other: Biorepair Toothpaste + Mousse
Control group
Active Comparator group
Description:
Biorepair Toothpaste domiciliary use.
Treatment:
Other: Biorepair Toothpaste

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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