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Recruiting NCT07029360

Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

No phase Interventional Pregnancy Periodontal Disease Gingivitis Dental Plaque

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Limosilactobacillus reuteri Prodentis®, Coenzyme Q10 Toothpaste.
Who it may be relevant to
Registry conditions: Pregnancy, Periodontal Disease, Gingivitis, Dental Plaque. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial

Overview

This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.

Interventions

  • Dietary supplement Limosilactobacillus reuteri Prodentis®
    Daily administration of Limosilactobacillus reuteri Prodentis® (1 oral tablet per day, taken after brushing in the evening), as an adjunct to non-surgical periodontal therapy and standard home care. Administered for 6 months only in the experimental arm.
  • Other Coenzyme Q10 Toothpaste
    Twice-daily use of a commercially available toothpaste containing coenzyme Q10, used as part of a home oral hygiene regimen for 6 months. All participants in both study arms will use the same toothpaste, with or without adjunctive probiotic supplementation.

Primary outcome measures

  • Change in Dental Plaque Measured by the Plaque Index Score [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
Secondary outcome measures (8)
  • Change in Gingival Bleeding Measured by the Bleeding on Probing (BoP) Index [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Periodontal Pocket Depth Measured by the Probing Pocket Depth (PPD) [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Clinical Attachment Level Measured by CAL [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Gingival Inflammation Measured by the Modified Gingival Index (MGI) [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Interproximal Plaque Measured by the Approximal Plaque Index (API) [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Plaque Distribution Measured by Plaque Control Record (PCR%) [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Gingival Inflammation Measured by the Papillary Marginal Gingival Index (PMGI) [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]
  • Change in Gingival Recession Measured by Clinical Examination [Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)]

Eligibility criteria

Inclusion criteria

  • Pregnant women between the 4th and 8th month of gestation
  • Age ≥ 18 years
  • Able to understand and communicate in Italian and/or English
  • Willing to provide written informed consent
  • Good compliance and willingness to follow study instructions

Exclusion criteria

  • Presence of cardiac pacemakers
  • Diagnosed psychological, neurological, or psychiatric disorders
  • Ongoing oncological therapy
  • Use of bisphosphonates within the last 12 months
  • Poor motivation or low compliance
  • Substance abuse (drugs or alcohol) or lifestyle incompatible with study requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Identifiers

NCT: NCT07029360 · 2025-Q10PROBIOPREG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗