PregnancyPREG-Q10NCT07029360
Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy
A study testing Limosilactobacillus reuteri Prodentis® and Coenzyme Q10 Toothpaste in people with Pregnancy and Periodontal Disease, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Periodontal Disease, Gingivitis
- What is being tested?
- Limosilactobacillus reuteri Prodentis® and Coenzyme Q10 Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
Andrea Scribante, Associate Professor, +39 0382516223, andrea.scribante@unipv.it
About this study
Official title: Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial
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
- Being tested
- Limosilactobacillus reuteri Prodentis®, Coenzyme Q10 Toothpaste
- 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
- Medical subject headings
- Periodontal Diseases, Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ToothpasteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Coenzyme Q10 Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The BoP index will be recorded to evaluate gingival bleeding. Comparison will be made between the test group (coenzyme Q10 + probiotics) and the control group (Q10 only) across all study timepoints, from baseline to 6 months. The BoP index is expressed as the percentage of bleeding sites out of the total number of sites examined (range: 0% to 100%), with higher percentages indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Periodontal Pocket Depth Measured by the Probing Pocket Depth (PPD)
PPD will be recorded in millimeters to assess periodontal pocket depth. Values will be compared between groups across timepoints to evaluate treatment efficacy. PPD values range from 1 mm (healthy sulcus) to over 7 mm (advanced periodontal disease); higher values indicate a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Clinical Attachment Level Measured by CAL
CAL will be measured to assess periodontal tissue support. The difference in attachment level from baseline to 6 months will be analyzed between study groups. CAL is measured in millimeters, typically ranging from 0 mm (no attachment loss) to over 10 mm in severe cases; higher values indicate a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Inflammation Measured by the Modified Gingival Index (MGI)
The MGI will be used to evaluate gingival inflammation. Score changes from baseline to 6 months will be analyzed between the intervention and control groups. The MGI ranges from 0 (normal gingiva) to 4 (severe inflammation), with higher scores indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Interproximal Plaque Measured by the Approximal Plaque Index (API)
The API will be used to assess the presence of plaque in interproximal areas. Changes in API scores will be compared between groups over the course of the study. The API is expressed as the percentage of interproximal sites with visible plaque (range: 0% to 100%), with higher values indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Plaque Distribution Measured by Plaque Control Record (PCR%)
The PCR% will measure the percentage of oral surfaces with plaque. The effect of the interventions on PCR% will be evaluated from baseline to 6 months. PCR% ranges from 0% (no plaque detected) to 100% (plaque present on all assessed surfaces), with higher values indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Inflammation Measured by the Papillary Marginal Gingival Index (PMGI)
The PMGI will be used to assess inflammation at the gingival margin and papilla. Differences in scores will be analyzed between groups at each follow-up. The PMGI ranges from 0 (normal gingiva) to 5 (severe inflammation with spontaneous bleeding), with higher scores indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Recession Measured by Clinical Examination
Gingival recession (R) will be clinically measured in millimeters to assess changes in gingival margin levels from baseline to 6 months, comparing both groups. Values typically range from 0 mm (no recession) to over 5 mm in severe cases, with higher values indicating a worse outcome.
Measured: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029360
- Sponsor's protocol ID
- 2025-Q10PROBIOPREG
- Acronym
- PREG-Q10
- Status last verified
- Feb 2026
- First submitted
- 11 Jun 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07029360
- Acronym / sponsor ID
- PREG-Q10 / 2025-Q10PROBIOPREG
- Conditions
- Pregnancy, Periodontal Disease, Gingivitis, Dental Plaque, Probiotics, Coenzyme Q10
- Keywords
- Bleeding on Probing, Clinical Attachment Loss, Coenzyme Q10, Dental Plaque, Gingival Inflammation, Gingivitis, Limosilactobacillus reuteri, Microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 Plus Probiotics | Experimental | Dietary Supplement: Limosilactobacillus reuteri Prodentis®, Other: Coenzyme Q10 ToothpasteParticipants 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. |
| Coenzyme Q10 Only | Active comparator | Other: Coenzyme Q10 ToothpasteParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Coenzyme Q10 Plus Probiotics |
| Coenzyme Q10 ToothpasteTwice-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. | Other | Coenzyme Q10 Only, Coenzyme Q10 Plus Probiotics |
Primary outcome
Change in Dental Plaque Measured by the Plaque Index Score
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
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.
8 secondary outcomes
Change in Gingival Bleeding Measured by the Bleeding on Probing (BoP) Index
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Periodontal Pocket Depth Measured by the Probing Pocket Depth (PPD)
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Clinical Attachment Level Measured by CAL
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Inflammation Measured by the Modified Gingival Index (MGI)
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Interproximal Plaque Measured by the Approximal Plaque Index (API)
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Plaque Distribution Measured by Plaque Control Record (PCR%)
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Inflammation Measured by the Papillary Marginal Gingival Index (PMGI)
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Change in Gingival Recession Measured by Clinical Examination
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Scribante, Associate Professor principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri Prodentis® and Coenzyme Q10 Toothpaste in people with Pregnancy and Periodontal Disease, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, Associate Professor (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dental Plaque Measured by the Plaque Index Score (time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.