An interventional study of Limosilactobacillus reuteri Prodentis® and Coenzyme Q10 Toothpaste in Pregnancy, Periodontal Disease and Gingivitis, sponsored by University of Pavia. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
Among 32 studies in Gingivitis with a site in Italy — 9 open to participants now, 10 under way, 1 of them phase 3. Gingivitis · Italy.
Among the 32 studies in Gingivitis with a site in Italy, this one is the 18th largest by planned enrollment of the 28 interventional ones, is one of 8 that started in 2025, is one of 22 with no phase, and was the 25th registered.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →9 of the 32 studies in Gingivitis with a site in Italy are open now, in 3 countries. Each count lists the studies.
Of the 53 Gingivitis studies recruiting now, 15 (28%) set no upper age limit and 36 (68%) stop at 75 or younger; 11 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 8 started in 2025.
Median enrollment 55 across the 28 interventional studies, 95 across the 4 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.
3 of 32 have an industry lead sponsor. The 10 most frequent:
University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
University of Pavia has 4 studies filed under Gingivitis — fewer than ten, so there is no comparison to draw.
1 of the studies in Gingivitis with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07842991Phase 3Colgate PalmoliveClinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems | 2027-01 |
Among the 32 studies in Gingivitis with a site in Italy, from their registry updates:
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
Compared within Gingivitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
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.
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)
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.
Time frame: 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.
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)
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.
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)
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
Plan to share: No — Data will be available upon motivated request to the corresponding authors.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
Of 204 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's planned 11 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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