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

NCT05400538 | Completed

• 1 other identifier: 2022-PREGNANCY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

pregnancy

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline, after 1, 3 and 6 months.

• 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%.

  Baseline, after 1, 3 and 6 months.

• Change in CAL - Clinical Attachment Loss

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

  Baseline, after 1, 3 and 6 months.

• Change in R - Gingival recession

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

  Baseline, after 1, 3 and 6 months.

• 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.

  Baseline, after 1, 3 and 6 months.

• 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)

  Baseline, after 1, 3 and 6 months.

• 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.

  Baseline, after 1, 3 and 6 months.

Study Arms (2)

Trial group

EXPERIMENTAL

Biorepair Toothpaste + Mousse domiciliary use

Other: Biorepair Toothpaste + Mousse

Control group

ACTIVE COMPARATOR

Biorepair Toothpaste domiciliary use.

Other: Biorepair Toothpaste

Interventions

Biorepair Toothpaste + Mousse OTHER

Domiciliary application of the products twice a day.

Trial group

Biorepair Toothpaste OTHER

Domiciliary application of the product twice a day.

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women at the 4th month of pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: June 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 20, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)