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Dental Plaque AccumulationNCT06984744

4-day Plaque Accumulation Model Evaluating Compound Containing Gum

A study testing MIIP-E2 containing gum in people with Dental Plaque Accumulation, run by Lactea Therapeutics, LLC at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dental Plaque Accumulation
What is being tested?
MIIP-E2 containing gum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
23 Jun 2025to 27 Feb 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult subjects between 18 and 65 years old
  • Willing to read and sign the IRB-approved informed consent.
  • Healthy, as determined by pertinent medical history at the study dentist's discretion.
  • A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
  • PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
  • Willing to comply with the study procedures.

Who cannot join

  • Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study.
  • Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect.
  • Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
  • Use of antibiotics 30 days prior to or during the study
  • Requiring the need for antibiotic premedication prior to dental procedures
  • Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
Show all 13Show fewer
  • Orthodontic appliances or any removable, except lingual bar retainers
  • Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
  • Self-reported allergy to disclosing solution ingredients (red dye #28)
  • Acute Temporomandibular Disorders (TMD)
  • Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening.
  • Subject who has previously been randomized in this study
  • An employee of the study site directly involved with the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Matthew Bender, PHD contact

12406565322

matt@agrilogicsgroup.com

Lorena Galvez contact

3172748838

logalvez@iu.edu

United States1 site, 1 recruiting

  • Oral Health Research Institute

    Indianapolis, Indiana, 46202

    Lorena Galvez, 317-274-8838, logalvez@iu.edu

    Recruiting

Other trials in United States

About this study

Official title: Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model

This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen).

Read the detailed description

treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen). Each subject will be assigned to one of the following three treatment regimen sequences:

  1. Control regimen followed by experimental regimen, followed by a negative control regimen, or
  2. Experimental regimen followed by negative control regimen, followed by control regimen or
  3. Negative control regimen followed by control regimen, followed by an experimental regimen Subjects will be asked to refrain from oral hygiene (OH) procedures and chewing gum 12 hours (+/- 2 hours) and from eating or drinking (except for water) 2 hours prior to the screening visit. During the 4-day study treatment periods, subjects will also be asked to refrain from oral hygiene practices or any elective dental treatment. Subjects can resume their regular oral hygiene procedures during the wash-out periods of approximately 10 days.

At the screening, potential subjects will be given the IRB (Institutional Review Board)-approved informed consent form to read and ask questions. Also, adequate time to decide about their participation will be provided. A study representative trained and delegated by the Principal Investigator will review the IRB-approved consent and answer any questions the potential subject might have before the subject signs/dates the consent. After the subject signs and dates the consent, the study representative will sign and date the consent to confirm that the consent process was completed before initiating any study procedures. The subject will be given a copy of the signed/dated consent.

A designated staff member will collect the medical and concomitant medication information for the study dentist's review. The dentist will perform an oral examination and a PLI to assess the subject's whole-mouth plaque accumulation. A score of 2 or greater will be needed to comply with the study inclusion criteria based on the Turesky modification of the Quigley and Hein Plaque Index (PLI). Other dental characteristics specified on the inclusion/ exclusion criteria will be assessed to determine study eligibility. Eligible subjects will receive a dental prophylaxis and be scheduled for a baseline appointment.

During the baseline appointment, the subjects' continuance criteria and OST (oral specimen test) examination will be assessed, and an unstimulated saliva sample will be collected. Subjects' teeth will be polished, flossed, and subsequently stained to evaluate total plaque removal and an oral assessment will be performed to confirm the complete removal of plaque. If any plaque is found, the plaque will be removed by either flossing, repolishing the surface, or with an instrument. The dental examiner will assess PLI. Intraoral photos will be taken, including one front and two lateral images (right and left side). 32 subjects will be enrolled and randomly assigned to one of the treatment regimens. Subjects assigned to experimental and negative treatment regimens will perform the first product use under supervision.

Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

The last product-use treatment will be after dinner the day before the visit. Subjects will refrain from eating or drinking (except water) for two hours before their appointment. They will also be asked to rinse their mouths with water approximately 30 minutes before their visit.

During the end of the treatment visit, subjects' continuance criteria will be assessed; the diary will be reviewed for compliance; an OST exam will be performed; and an unstimulated saliva sample will be collected. Subjects will rinse with a disclosing solution to reveal the accumulation of dental plaque. Intraoral photos, including one front and two lateral images (right and left sides), will be taken. Afterward, the examiner will assess the PLI, and subjects will be taken to a brushing station to brush their teeth using a provided toothbrush, fluoride-containing toothpaste, and dental floss. They will be scheduled for the next visit after a washout period of approximately 10 days.

For treatments 2 and 3, the procedures mentioned in the baseline visit will be repeated (except for randomization). A new product (or no product) will be given according to the randomization assignment. The end of the treatment visit will be repeated on the fourth day of each treatment period.

Lactea Therapeutics has formulated a gum product containing an active innate immune protein, MIIP-E2. This product is an ultrapure (>99%) fully native and completely active form of bovine lactoferrin extracted and purified directly from raw milk. MIIP-E2 aims to develop a field-deployable dental care solution to enhance on-the-go oral care targeting military use. Due to the capability of the MIIP-E2 gum to coat the inner surfaces of the mouth, it can function as a barrier to biofilm adherence. The dosage of MIIP-E2 proposed for use in this study is dramatically below these acceptable levels in milk-based infant formulas, which range between 101.3 and 60.1 mg daily.

Being tested
MIIP-E2 containing gum, placebo gum without MIIP-E2
Keywords
dental plaque, gum chewing
Medical subject headings
Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIIP-E2 containing gumDevice

    Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit. MIIP-E2 is an ultrapure (>99%) fully native and completely active form of bovine lactoferrin purified directly from raw milk.

  • placebo gum without MIIP-E2Device

    Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

Study groups in NCT06984744
Study groupRoleWhat they receive
Control regimenNo interventionSubjects will chew no gum during this regimen. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Subjects in the no intervention regimen will use no gum. Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.
Intervention Experimental MIIP-E2 regimenExperimentalGum will contain gum base with 30mg of compound being evaluated. Gum will contain gum base only without compound being evaluated. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.
Receives: Device: MIIP-E2 containing gum
Negative control regimenPlacebo comparatorGum will contain gum base only without compound being evaluated. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.
Receives: Device: placebo gum without MIIP-E2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dental plaque

    Dental plaque was identified using a disclosing solution and scored using the Turesky modification of the Quigley-Hein Plaque Index (PLI). The index score was scored between 0 and 5, with 0 = no plaque detected and 5= = Plaque covering 2/3 or more of the tooth's crown. The remaining values are based on the amount of plaque covering the tooth. The higher the score, the more plaque accumulated and the worse the outcome for the surface. Each tooth, except the third molars, will be scored at six sites: Mesio-Buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual. The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined. A score would range from 0.1 to 3.0 (0.1-1.0= = mild inflammation; 1.1-2.0= = moderate inflammation; and 2.1-3.0= = severe inflammation).

    Measured: At the end of 4 days of intervention.

Secondary outcomes (2)

  1. 16S sequencing

    In addition, patient saliva samples will be taken before and after each treatment regimen for 16S rRNA (ribosomal ribonucleic acid) microbiome sequencing using the Qiagen PAXgene Saliva Collector and protocols that accompany the collection kit (https://www.qiagen.com /us/products/discovery-and-translational-research/sample-collection-stabilization/dna/pax gene-saliva-collector). Sequencing will be performed at CD Genomics (a third-party vendor) using protocols for full-length PacBio (Pacific Biosciences) sequencing and IRB#: 25945 Version Date: February 3, 2025 Page 6 of 18 analyzed using standard methodologies to identify microbial taxonomy. No human genetic information will be collected or analyzed using this methodology.

    Measured: At the end of 4 days of intervention.

  2. Dental Plaque Visual Assessment with photographs

    Images of dental plaque will be used for both qualitative representations of outcomes in future reports as well as used as a secondary, complementary quantitative analysis for the PLI assessment. For the quantitative analysis, plaque coverage on teeth will be assessed using an image thresholding area measurement as previously described. This analysis is anticipated to provide similar results to the PLI as mentioned earlier but may allow for further analysis and quantitative precision. Depending on preliminary analysis, these measurements may be used to further assess details of product efficacy, such as regional changes in plaque across teeth, to understand whether the reduction in plaque occurred primarily on surfaces with direct exposure to the gum or throughout the mouth.

    Measured: At the end of 4 days of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start23 Jun 2025
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion27 Feb 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects who previously participated in other Oral Health Research Institute studies (OHRI) or who have contacted OHRI expressing interest in potential studies will be contacted by a team member who will conduct a screening phone interview. If the potential subjects appear to qualify, they will be scheduled for the screening visit. A sufficient number of subjects will be screened to participate, and 32 will be randomized to finish with at least 30 subjects. We intend to randomize a nearly equal number of female and male subjects. A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned according to appearance at the study site. Subjects who meet all inclusion and exclusion criteria will be randomized into the study. Block randomization will be used to assign subjects to one of the three treatment regimen sequences: 1\. Control regimen (Tx 3) followed by experimental regimen (Tx 1), followed by a negative control (Tx 2), or
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984744
Sponsor's protocol ID
LAC_IU_2025_plaque
Status last verified
May 2025
First submitted
14 May 2025
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Claydon NC, Hall C, Hughes AJ, Shaw D, Seong J, Davies M, West NX. Randomized controlled trial to study plaque inhibition in calcium sodium phosphosilicate dentifrices. J Dent. 2016 Mar;46:61-7. doi: 10.1016/j.jdent.2016.01.003. Epub 2016 Jan 12.

    PubMed 26796897

  • Smith RN, Brook AH, Elcock C. The quantification of dental plaque using an image analysis system: reliability and validation. J Clin Periodontol. 2001 Dec;28(12):1158-62. doi: 10.1034/j.1600-051x.2001.281211.x.

    PubMed 11737514

  • Buetas E, Jordan-Lopez M, Lopez-Roldan A, D'Auria G, Martinez-Priego L, De Marco G, Carda-Dieguez M, Mira A. Full-length 16S rRNA gene sequencing by PacBio improves taxonomic resolution in human microbiome samples. BMC Genomics. 2024 Mar 25;25(1):310. doi: 10.1186/s12864-024-10213-5.

    PubMed 38528457

  • Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

    PubMed 5264376

  • Morita Y, Ishikawa K, Nakano M, Wakabayashi H, Yamauchi K, Abe F, Ooka T, Hironaka S. Effects of lactoferrin and lactoperoxidase-containing food on the oral hygiene status of older individuals: A randomized, double blinded, placebo-controlled clinical trial. Geriatr Gerontol Int. 2017 May;17(5):714-721. doi: 10.1111/ggi.12776. Epub 2016 May 6.

    PubMed 27150460

  • Nakano M, Yoshida A, Wakabayashi H, Tanaka M, Yamauchi K, Abe F, Masuda Y. Effect of tablets containing lactoferrin and lactoperoxidase on gingival health in adults: A randomized, double-blind, placebo-controlled clinical trial. J Periodontal Res. 2019 Dec;54(6):702-708. doi: 10.1111/jre.12679. Epub 2019 Jul 10.

    PubMed 31292969

  • Arslan SY, Leung KP, Wu CD. The effect of lactoferrin on oral bacterial attachment. Oral Microbiol Immunol. 2009 Oct;24(5):411-6. doi: 10.1111/j.1399-302X.2009.00537.x.

    PubMed 19702956

  • Velusamy SK, Markowitz K, Fine DH, Velliyagounder K. Human lactoferrin protects against Streptococcus mutans-induced caries in mice. Oral Dis. 2016 Mar;22(2):148-54. doi: 10.1111/odi.12401. Epub 2016 Jan 18.

    PubMed 26601919

  • Berlutti F, Pilloni A, Pietropaoli M, Polimeni A, Valenti P. Lactoferrin and oral diseases: current status and perspective in periodontitis. Ann Stomatol (Roma). 2011 Mar;2(3-4):10-8. Epub 2012 Jan 27.

    PubMed 22545184

  • Yamauchi K, Toida T, Nishimura S, Nagano E, Kusuoka O, Teraguchi S, Hayasawa H, Shimamura S, Tomita M. 13-Week oral repeated administration toxicity study of bovine lactoferrin in rats. Food Chem Toxicol. 2000 Jun;38(6):503-12. doi: 10.1016/s0278-6915(00)00036-3.

    PubMed 10828502

  • Cao X, Ren Y, Lu Q, Wang K, Wu Y, Wang Y, Zhang Y, Cui XS, Yang Z, Chen Z. Lactoferrin: A glycoprotein that plays an active role in human health. Front Nutr. 2023 Jan 5;9:1018336. doi: 10.3389/fnut.2022.1018336. eCollection 2022.

    PubMed 36712548

  • Drago-Serrano ME, de la Garza-Amaya M, Luna JS, Campos-Rodriguez R. Lactoferrin-lipopolysaccharide (LPS) binding as key to antibacterial and antiendotoxic effects. Int Immunopharmacol. 2012 Jan;12(1):1-9. doi: 10.1016/j.intimp.2011.11.002. Epub 2011 Nov 18.

    PubMed 22101278

  • Smith AJ, Moran J, Dangler LV, Leight RS, Addy M. The efficacy of an anti-gingivitis chewing gum. J Clin Periodontol. 1996 Jan;23(1):19-23. doi: 10.1111/j.1600-051x.1996.tb00499.x.

    PubMed 8636452

  • Weber J, Scholz KJ, Schenke IM, Pfab F, Cieplik F, Hiller KA, Buchalla W, Sahm C, Kirschneck C, Paddenberg-Schubert E. Randomized controlled clinical trial on the efficacy of a novel antimicrobial chewing gum in reducing plaque and gingivitis in adolescent orthodontic patients. Clin Oral Investig. 2024 Apr 25;28(5):272. doi: 10.1007/s00784-024-05669-4.

    PubMed 38664261

  • Takenouchi A, Saeki Y, Otani E, Kim M, Fushimi A, Satoh Y, Kakegawa Y, Arai H, Taguchi N, Matsukubo T. Effects of Chewing Gum Base on Oral Hygiene and Mental Health: A Pilot Study. Bull Tokyo Dent Coll. 2021 Mar 13;62(1):7-14. doi: 10.2209/tdcpublication.2020-0009. Epub 2021 Feb 15.

    PubMed 33583877

Questions about this trial

What is this clinical trial studying?

A study testing MIIP-E2 containing gum in people with Dental Plaque Accumulation, run by Lactea Therapeutics, LLC at 1 site in United States.

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 13 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 27 Aug 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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 Matthew Bender, PHD (12406565322, matt@agrilogicsgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dental plaque (time frame: At the end of 4 days of intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06984744, which also lists 24 linked publications.

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 27 Aug 2025.

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