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Completed

NCT Number: NCT05400538

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

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biorepair Toothpaste + Mousse

Other

Domiciliary application of the products twice a day.

Biorepair Toothpaste

Other

Domiciliary application of the product twice a day.

Primary outcomes

  1. Change in PPD - Probing Pocket Depth

    Time frame: Baseline, after 1, 3 and 6 months.

    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.

  2. Change in BOP - Bleeding on Probing (percentage)

    Time frame: Baseline, after 1, 3 and 6 months.

    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%.

  3. Change in CAL - Clinical Attachment Loss

    Time frame: Baseline, after 1, 3 and 6 months.

    Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).

  4. Change in R - Gingival recession

    Time frame: Baseline, after 1, 3 and 6 months.

    Distance (in mm) between the gingival margin and the amelo-cemental junction.

  5. Change in PCR% - Plaque Control Record

    Time frame: Baseline, after 1, 3 and 6 months.

    % 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.

  6. Change in MGI - Modified Gingival Index

    Time frame: Baseline, after 1, 3 and 6 months.

    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)

  7. Change in PMGI - Papillary Marginal Gingival Index

    Time frame: Baseline, after 1, 3 and 6 months.

    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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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