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Enrolling by Invitation

NCT Number: NCT06308497

Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women

The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Pregnancy Related Stomatognathic Diseases

Age range

18 year–40 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 study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.

At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).

Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.

Subsequently, patients will be randomly divided into two groups:

  • the Probiotic group, in which patients will undergo daily probiotic supplementation in addition to the standard treatment
  • the Control group, in which patients will undergo standard treatment

Professional debridement will be repeated every 3 months. Periodontal index evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).

Who can participate

Healthy volunteers accepted: No

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

Probiotic Treatment

Other

Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day Probiotic supplementation with daily assumption of Limosilactobacillus Reuteri Prodentis® tablet (PerioBalance, Gum®)

standard treatment

Other

Professional in-office debridement every 3 months Use of soft-picks® advanced interdental cleaners (Gum®) followed by toothbrushing with ActiVital toothpaste (Gum®) with coenzyme Q10 and sonic daily electric toothbrush (Gum®) twice a day

Primary outcomes

  1. Change in Plaque Index

    Time frame: Baseline, 1, 3 and 6 months

    Scoring criteria:

    0 = no plaque;

    • = thin plaque layer at the gingival margin, only detectable by scraping with a probe;
    • = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye;
    • = abundant plaque along the gingival margin; interdental spaces filled with plaque.

  2. Change in Recession (R)

    Time frame: Baseline, 1, 3 and 6 months

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

  3. Change in Clinical Attachment Loss (CAL)

    Time frame: Baseline, 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 Bleeding on Probing (BoP)

    Time frame: Baseline, 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%.

  5. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline, 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.

  6. Change in API - Approximal Plaque Index

    Time frame: Baseline, 1, 3 and 6 months

    Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3).

  7. Change in Plaque Control Record (PCR%)

    Time frame: Baseline, 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.

  8. Change in Papillary Marginal Gingival Index (PMGI)

    Time frame: Baseline, 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.

  9. Change in modified Marginal Gingival Index (mMGI)

    Time frame: Baseline, 1, 3 and 6 months

    Scoring criteria:

    0 = Absence of inflammation

    • = Mild inflammation (marginal or papillary unit)
    • = Mild inflammation (entire marginal and papillary unit)
    • = Moderate inflammation
    • = Severe inflammation

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women: Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Jan 22, 2025

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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