Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

NCT ID: NCT07029360

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Periodontal Disease Gingivitis Dental Plaque Probiotics Coenzyme Q10 Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coenzyme Q10 Plus Probiotics

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.

Group Type EXPERIMENTAL

Limosilactobacillus reuteri Prodentis®

Intervention Type DIETARY_SUPPLEMENT

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.

Coenzyme Q10 Toothpaste

Intervention Type OTHER

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.

Coenzyme Q10 Only

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.

Group Type ACTIVE_COMPARATOR

Coenzyme Q10 Toothpaste

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Scribante, Associate Professor

Role: CONTACT

+39 0382516223

Facility Contacts

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Andrea Scribante, Associate Professor

Role: primary

+39 0382516223

Other Identifiers

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2025-Q10PROBIOPREG

Identifier Type: -

Identifier Source: org_study_id

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