Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy (PREG-Q10)

University of Pavia

Status: Enrolling

Conditions: Dental Plaque; Coenzyme Q10; Probiotics; Periodontal Disease; Microbiota; Gingivitis; Pregnancy

Treatments: Other: Coenzyme Q10 Toothpaste; Dietary Supplement: Limosilactobacillus reuteri Prodentis®

Study type: Interventional

Funder types: Other

Identifiers

NCT07029360

2025-Q10PROBIOPREG

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Coenzyme Q10 Plus Probiotics

Experimental group

Description:

Participants assigned to this arm will undergo professional oral hygiene every three months and will follow a home-care regimen consisting of twice-daily use of a coenzyme Q10-based toothpaste combined with a daily probiotic supplement (Limosilactobacillus reuteri Prodentis®, 1 tablet per day) for 6 months. Additional hygiene tools include soft picks and a sonic toothbrush.

Treatment:

Other: Coenzyme Q10 Toothpaste

Dietary Supplement: Limosilactobacillus reuteri Prodentis®

Coenzyme Q10 Only

Active Comparator group

Description:

Participants assigned to this arm will undergo professional oral hygiene every three months and will follow a home-care regimen consisting of twice-daily use of a coenzyme Q10-based toothpaste for 6 months, without probiotics. Additional hygiene tools include soft picks and a sonic toothbrush.

Treatment:

Other: Coenzyme Q10 Toothpaste