Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

NCT07029360 | Recruiting

• 1 other identifier: 2025-Q10PROBIOPREG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bleeding on Probing; Clinical Attachment Loss; Coenzyme Q10; Dental Plaque; Gingival Inflammation; Gingivitis; Limosilactobacillus reuteri; Microbiota; Non-Surgical Periodontal Treatment; Oral Microbiota; Periodontal Therapy; Plaque Control; Plaque Index; Pregnancy; Pregnant Women; Probiotics; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Dental Plaque Measured by the Plaque Index Score

  The Plaque Index (PI) Score will be recorded at four timepoints (baseline, 1 month, 3 months, and 6 months) to assess the amount of dental plaque accumulation. The primary endpoint is the change in PI from baseline (T0) to 6 months (T3), comparing the intervention group (coenzyme Q10 + probiotics) to the control group (coenzyme Q10 only). The index is measured by visually scoring the plaque on tooth surfaces using standardized criteria. The Plaque Index score ranges from 0 (no plaque) to 3 (abundant plaque), with higher scores indicating a worse outcome.

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

Secondary Outcomes (8)

• Change in Gingival Bleeding Measured by the Bleeding on Probing (BoP) Index

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

• Change in Periodontal Pocket Depth Measured by the Probing Pocket Depth (PPD)

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

• Change in Clinical Attachment Level Measured by CAL

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

• Change in Gingival Inflammation Measured by the Modified Gingival Index (MGI)

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

• Change in Interproximal Plaque Measured by the Approximal Plaque Index (API)

  Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)

Study Arms (2)

Coenzyme Q10 Plus Probiotics

EXPERIMENTAL

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.

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

Coenzyme Q10 Only

ACTIVE COMPARATOR

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.

Other: Coenzyme Q10 Toothpaste

Interventions

Limosilactobacillus reuteri Prodentis® 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 Plus Probiotics

Coenzyme Q10 Toothpaste 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; Coenzyme Q10 Plus Probiotics

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who self-identify as female and are biologically pregnant are eligible to participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)