PregnancyLBC-PREGNCT07069140
Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
A study testing Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) and Lactoferrin-Based Toothpaste Only (Emoform Glic) 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 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Periodontal Disease, Gingivitis
- What is being tested?
- Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) and Lactoferrin-Based Toothpaste Only (Emoform Glic)
- 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
- 30 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged between 18 and 45 years
- Gestational age between 14 and 28 weeks at the time of enrollment (second trimester)
- Diagnosis of periodontitis according to the 2017 World Workshop classification (Stages I-III, Grades A-B)
- Presence of at least 20 natural teeth
- Willingness to comply with study procedures and attend follow-up visits
- Signed informed consent
Who cannot join
- History of systemic diseases that could affect periodontal status (e.g., diabetes mellitus, immunosuppression)
- Antibiotic or anti-inflammatory therapy within 3 months prior to enrollment Current use of probiotics, antioxidant supplements, or medicated mouthwashes
- Periodontal treatment within 6 months before enrollment
- High-risk pregnancy or pregnancy complications (e.g., preeclampsia, gestational diabetes)
- Smoking or tobacco use
- Known allergy to any of the investigational product components
- Participation in another clinical trial within the previous 3 months
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: Effectiveness of an Oral Care Protocol Based on Lactoferrin Toothpaste and Mouthwash in Pregnant Women for the Prevention of Periodontal Disease: A Randomized Controlled Clinical Trial
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.
- Conditions
- Pregnancy, Periodontal Disease, Gingivitis, Oral Microbiota
- Being tested
- Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic), Lactoferrin-Based Toothpaste Only (Emoform Glic)
- Keywords
- Lactoferrin, Pregnancy, Periodontal Disease, Oral Microbiota, Dental Plaque, Gingivitis, Non-surgical Periodontal Therapy, Toothpaste, Mouthwash, LBC Complex, Maternal Oral Health, Randomized Controlled Trial, Oral Hygiene in Pregnancy
- 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.
Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)Drug
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.
Lactoferrin-Based Toothpaste Only (Emoform Glic)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin Toothpaste + Mouthwash | Experimental | 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. Receives: Drug: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) |
| Lactoferrin Toothpaste | Active comparator | 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. Receives: Drug: Lactoferrin-Based Toothpaste Only (Emoform Glic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (
Measured: Baseline (T0) to Month 6 (T3)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0) to Month 6 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start30 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
- NCT07069140
- Sponsor's protocol ID
- 2025-LBCGEST
- Acronym
- LBC-PREG
- Status last verified
- Feb 2026
- First submitted
- 5 Jul 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
- Effectiveness of an Oral Care Protocol Based on Lactoferrin Toothpaste and Mouthwash in Pregnant Women for the Prevention of Periodontal Disease: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07069140
- Acronym / sponsor ID
- LBC-PREG / 2025-LBCGEST
- Conditions
- Pregnancy, Periodontal Disease, Gingivitis, Oral Microbiota
- Keywords
- Lactoferrin, Pregnancy, Periodontal Disease, Oral Microbiota, Dental Plaque, Gingivitis, Non-surgical Periodontal Therapy, Toothpaste
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 16 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin Toothpaste + Mouthwash | Experimental | Drug: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)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. |
| Lactoferrin Toothpaste | Active comparator | Drug: Lactoferrin-Based Toothpaste Only (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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged between 18 and 45 years
- Gestational age between 14 and 28 weeks at the time of enrollment (second trimester)
- Diagnosis of periodontitis according to the 2017 World Workshop classification (Stages I-III, Grades A-B)
- Presence of at least 20 natural teeth
- Willingness to comply with study procedures and attend follow-up visits
Key exclusion criteria (7 listed)
- History of systemic diseases that could affect periodontal status (e.g., diabetes mellitus, immunosuppression)
- Antibiotic or anti-inflammatory therapy within 3 months prior to enrollment Current use of probiotics, antioxidant supplements, or medicated mouthwashes
- Periodontal treatment within 6 months before enrollment
- High-risk pregnancy or pregnancy complications (e.g., preeclampsia, gestational diabetes)
- Smoking or tobacco use
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 |
|---|---|---|
| Lactoferrin-based Toothpaste and Mouthwash (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. | Drug | Lactoferrin Toothpaste + Mouthwash |
| Lactoferrin-Based Toothpaste Only (Emoform Glic)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. | Drug | Lactoferrin Toothpaste |
Primary outcome
Change in dental plaque accumulation measured by Plaque Index (PI)
Time frame: Baseline (T0) to Month 6 (T3)
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 (
8 secondary outcomes
Change in gingival bleeding measured by Bleeding on Probing (BoP)
Time frame: Baseline (T0) to Month 6 (T3)
Change in periodontal pocket depth measured by Probing Pocket Depth (PPD)
Time frame: Baseline (T0) to Month 6 (T3)
Change in connective tissue attachment loss measured by Clinical Attachment Level (CAL)
Time frame: Baseline (T0) to Month 6 (T3)
Change in gingival inflammation severity measured by Modified Gingival Index (MGI)
Time frame: Baseline (T0) to Month 6 (T3)
Change in interproximal plaque accumulation measured by Approximal Plaque Index (API)
Time frame: Baseline (T0) to Month 6 (T3)
Change in global plaque distribution measured by Plaque Control Record (PCR%)
Time frame: Baseline (T0) to Month 6 (T3)
Change in localized gingival inflammation measured by Papillary-Marginal-Gingival Index (PMGI)
Time frame: Baseline (T0) to Month 6 (T3)
Change in soft tissue loss measured by Gingival Recession (R)
Time frame: Baseline (T0) to Month 6 (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 Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) and Lactoferrin-Based Toothpaste Only (Emoform Glic) 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 6 inclusion and 7 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 accumulation measured by Plaque Index (PI) (time frame: Baseline (T0) to Month 6 (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.