RecruitingNot ApplicableNCT07029360

Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

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


Sponsor

University of Pavia

Enrollment

40 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DIETARY_SUPPLEMENTLimosilactobacillus 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.

OTHERCoenzyme 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.


Locations(1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

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NCT07029360


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