Coenzyme Q10 toothpaste with daily Limosilactobacillus reuteri probiotics to improve gum health during pregnancy
Official title: Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial
Run by University of Pavia · NCT07029360 · Data updated 2026-11-12
For pregnant women with gum disease, this will try whether adding a CoQ10 toothpaste and daily L. reuteri probiotic to regular cleanings reduces plaque and gum bleeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 10, 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07029360 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 or older between the 4th and 8th month of gestation who can understand Italian or English, provide informed consent, and are willing to comply with study visits and instructions are ideal candidates.
✕Probably not a fit
Individuals with cardiac pacemakers, active oncologic therapy, recent bisphosphonate use, significant psychiatric or substance-abuse issues, poor compliance, or those outside the specified gestational window are unlikely to be eligible or receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 40 pregnant women between the 4th and 8th month of gestation and randomize them to two groups. The test group will receive professional oral hygiene every three months plus a CoQ10-based toothpaste and daily Limosilactobacillus reuteri Prodentis® probiotic, while the control group will follow the same protocol without probiotics. The primary outcome is change in Plaque Index over a 6-month follow-up; secondary outcomes include Bleeding on Probing, probing pocket depth, clinical attachment level, gingival inflammation indices, plaque distribution metrics, and gingival recession. The protocol aims to see if the combined therapy promotes a balanced oral microbiota and improves periodontal measures during pregnancy.
Why it matters
Potential benefit: If successful, the combination could reduce plaque and gum inflammation in pregnant women and lower the risk of pregnancy-related periodontal complications.
How similar studies have gone: Prior studies in non-pregnant adults have shown modest gum-health benefits from probiotics and from CoQ10 separately, but combining these interventions specifically during pregnancy is relatively untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy Recruiting
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.