An interventional study of Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) and Lactoferrin-Based Toothpaste Only (Emoform Glic) in Pregnancy, Periodontal Disease and Gingivitis, sponsored by University of Pavia. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. 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 26th 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 to 45 Years · 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 a lactoferrin-based oral hygiene protocol in improving periodontal health during pregnancy. Forty pregnant women between the fourth and eighth month of gestation will be enrolled and randomly assigned to one of two groups. The trial group will undergo professional dental cleaning every three months and will perform home oral hygiene using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic) twice daily. The control group will follow the same schedule of professional dental cleanings but will use only the lactoferrin-based toothpaste (Emoform Glic) at home. The primary objective is to assess the reduction in dental plaque, measured by the Plaque Index (PI). Secondary outcomes include improvements in gingival inflammation, probing pocket depth, clinical attachment level, and other periodontal indices. Participants will be followed for six months, with evaluations conducted at baseline, 1, 3, and 6 months.
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 →
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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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will undergo professional dental hygiene sessions every 3 months and will perform home oral care using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic). They will be instructed to brush their teeth twice daily using the toothpaste and to rinse with 10 mL of mouthwash for 60 seconds twice daily, for a total study duration of 6 months. The intervention aims to evaluate the added benefit of combining both products on plaque accumulation and periodontal inflammation in pregnant women between the 4th and 8th month of gestation.
Drug: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)
Participants randomized to this arm will also undergo professional dental hygiene sessions every 3 months. For home care, they will use only the lactoferrin-based toothpaste (Emoform Glic), brushing twice daily for 2 minutes following standard oral hygiene instructions. No mouthwash will be used. This group serves as the active comparator to determine whether the addition of the lactoferrin-based mouthwash provides any significant clinical advantage.
Drug: Lactoferrin-Based Toothpaste Only (Emoform Glic)
Participants in the experimental arm will receive professional supragingival and subgingival dental hygiene sessions every three months over a six-month period. In addition, they will follow a home oral care protocol consisting of twice-daily use of a lactoferrin-based toothpaste and a lactoferrin-based mouthwash, both commercially available as Emoform Glic (Polifarma Benessere S.r.l.). The toothpaste will be applied with a soft-bristle toothbrush for two minutes, and the mouthwash will be used at a dosage of 10 mL, rinsed for 60 seconds after toothbrushing, twice a day. The intervention aims to assess whether the combined use of lactoferrin-based toothpaste and mouthwash can enhance clinical outcomes related to plaque accumulation and periodontal inflammation in pregnant women between the fourth and eighth month of gestation.
Participants in the control arm will also undergo professional dental hygiene sessions every three months for a total duration of six months. At home, they will follow an oral hygiene protocol limited to the twice-daily use of a lactoferrin-based toothpaste (Emoform Glic, Polifarma Benessere S.r.l.), applied with a soft-bristle toothbrush for two minutes. No mouthwash will be used in this arm. The purpose of this intervention is to evaluate the effectiveness of lactoferrin toothpaste alone and to serve as an active comparator for assessing the additional benefit of the mouthwash in improving periodontal parameters.
Change in dental plaque accumulation measured by Plaque Index (PI)
The primary outcome of this study is the change in dental plaque levels assessed using the Plaque Index (PI) developed by Silness and Löe. This index measures the thickness of dental plaque at the gingival margin. For each participant, four surfaces of each tooth (buccal, lingual, mesial, and distal) are examined and scored on a scale from 0 to 3. A score of 0 corresponds to the absence of plaque. A score of 1 indicates the presence of a plaque film only visible with a disclosing agent or by using a periodontal probe. A score of 2 indicates visible moderate plaque accumulation at the gingival margin, while a score of 3 reflects heavy plaque deposits within the gingival sulcus and around the gingival margin. The final PI for each subject is obtained by calculating the mean of all recorded surface scores. This measure provides a continuous variable where higher scores represent greater plaque accumulation and worse oral hygiene. The index will be recorded at four time points: baseline (
Time frame: Baseline (T0) to Month 6 (T3)
Change in gingival bleeding measured by Bleeding on Probing (BoP)
This outcome assesses the degree of gingival inflammation by measuring the percentage of sites exhibiting bleeding after gentle probing of the gingival sulcus using a calibrated periodontal probe. BoP is recorded dichotomously, assigning a score of 0 to non-bleeding sites and 1 to bleeding sites. The final BoP score is calculated as the proportion of bleeding sites over the total number of examined sites, expressed as a percentage. Higher percentages indicate more severe inflammation. BoP values will be collected at baseline and at 1, 3, and 6 months to compare the anti-inflammatory effectiveness of the two home care protocols.
Time frame: Baseline (T0) to Month 6 (T3)
Change in periodontal pocket depth measured by Probing Pocket Depth (PPD)
This outcome measures the depth of the gingival sulcus or periodontal pocket using a periodontal probe. Probing Pocket Depth (PPD) is defined as the distance, in millimeters, from the free gingival margin to the bottom of the sulcus or pocket. Six sites per tooth are examined, and the average depth per participant is calculated. Deeper pockets reflect more severe periodontal involvement. PPD scores will be compared between the experimental and control groups at baseline, 1, 3, and 6 months to evaluate the effect of the lactoferrin-based mouthwash in addition to toothpaste.
Time frame: Baseline (T0) to Month 6 (T3)
Change in connective tissue attachment loss measured by Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) represents the cumulative loss of periodontal supporting tissue and is calculated as the distance from the cementoenamel junction (CEJ) to the base of the sulcus or periodontal pocket. It is measured in millimeters at six sites per tooth using a calibrated probe. Improvements in CAL over time reflect periodontal healing or stabilization.
Time frame: Baseline (T0) to Month 6 (T3)
Change in gingival inflammation severity measured by Modified Gingival Index (MGI)
The Modified Gingival Index (MGI) is a non-invasive visual index that evaluates gingival inflammation based on changes in color, consistency, and swelling of the marginal tissues. Scores range from 0 (normal, healthy gingiva) to 4 (severe inflammation with spontaneous bleeding). It does not require probing. The mean score per patient is used to assess the effectiveness of treatment.
Time frame: Baseline (T0) to Month 6 (T3)
Change in interproximal plaque accumulation measured by Approximal Plaque Index (API)
The Approximal Plaque Index (API) quantifies dental plaque located on interproximal surfaces. After applying a disclosing agent, the presence or absence of plaque is visually evaluated on approximal areas. The score is calculated as the percentage of plaque-positive sites over the total number of interproximal sites examined. Lower values indicate better interproximal hygiene.
Time frame: Baseline (T0) to Month 6 (T3)
Change in global plaque distribution measured by Plaque Control Record (PCR%)
The Plaque Control Record (PCR%) provides an overview of plaque presence across all four surfaces (buccal, lingual, mesial, distal) of each tooth. After staining with a plaque disclosing agent, the number of plaque-positive surfaces is recorded and divided by the total number of surfaces examined, expressed as a percentage. This index is used to monitor the effectiveness of plaque control strategies.
Time frame: Baseline (T0) to Month 6 (T3)
Change in localized gingival inflammation measured by Papillary-Marginal-Gingival Index (PMGI)
The Papillary-Marginal-Gingival Index (PMGI) assesses inflammation specifically in the interdental papilla and marginal gingiva through visual inspection. Scores range from 0 (normal appearance) to 5 (severe inflammation with ulceration and spontaneous bleeding). This score allows detection of early localized inflammatory changes not always reflected in broader indices.
Time frame: Baseline (T0) to Month 6 (T3)
Change in soft tissue loss measured by Gingival Recession (R)
Gingival Recession (R) is defined as the apical migration of the gingival margin with respect to the cementoenamel junction (CEJ), measured in millimeters. It reflects soft tissue loss and root exposure. Clinical measurements are used to monitor whether the intervention prevents further recession or contributes to soft tissue stabilization.
Time frame: Baseline (T0) to Month 6 (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, 10 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 10 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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