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Recruiting NCT07029360

NCT07029360 Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

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Clinical Trial Summary
NCT ID NCT07029360
Status Recruiting
Phase —
Sponsor University of Pavia
Condition Pregnancy
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2025-07-01
Primary Completion 2026-06-01

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Limosilactobacillus reuteri Prodentis®Coenzyme Q10 Toothpaste

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2025-07-01 with a primary completion date of 2026-06-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

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

Contact & Investigator

Central Contact

Andrea Scribante, Associate Professor

✉ andrea.scribante@unipv.it

📞 +39 0382516223

Principal Investigator

Andrea Scribante, Associate Professor

PRINCIPAL INVESTIGATOR

University of Pavia

Frequently Asked Questions

Who can join the NCT07029360 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07029360 currently recruiting?

Yes, NCT07029360 is actively recruiting participants. Contact the research team at andrea.scribante@unipv.it for enrollment information.

Where is the NCT07029360 trial being conducted?

This trial is being conducted at Pavia, Italy.

Who is sponsoring the NCT07029360 clinical trial?

NCT07029360 is sponsored by University of Pavia. The principal investigator is Andrea Scribante, Associate Professor at University of Pavia. The trial plans to enroll 40 participants.

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