Dental PlaquePhase 1NCT02617407
Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients
A Phase 1 study testing Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste and Kolibree Toothbrush in people with Dental Plaque, run by University of California, San Francisco at 1 site in United States.
Trial summary
Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste and Kolibree Toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2016to 27 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HSCT recipient or chemo/radiation therapy patients who can cooperate with study procedures.
- Parents and patient willing to participate and sign informed consent and assent forms.
Who cannot join
- Unable to understand or participate in study procedures.
- Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94115
About this study
Official title: Pilot Study -- Oral Microbiome and Dental Plaque Control With Livionex(R) in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in reducing dental plaques while containing no additives found in other toothpastes that can cause increased gingival irritation. The investigators hypothesize that improved oral hygiene and better plaque control in pediatric patients receiving chemo/radiation treatment or HSCT may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot study is to determine whether incorporation of the Livionex® toothpaste in the research regimen could reduce dental plaque.
Read the detailed description
This is a prospective randomized (2:1) pilot study of children undergoing HSCT or chemo/radiation therapy for cancer treatment who are able to cooperate with saliva collection and dental exams.
RATIONALE:
As chemotherapy and radiation therapy result in a break-down of the mucosal barrier, HSCT recipients and cancer patients are at a significant risk for bacteremia and sepsis from oral pathogens. Children undergoing HSCT have significant difficulties achieving good oral hygiene and dental plaque control because of sensitivity of oral tissues leading to intolerance of teeth brushing and standard dentifrice. This usually results in plaque buildup and moderate to severe gingival inflammation, which persists during and after transplantation. The investigators hypothesize that improved oral hygiene and better plaque control in HSCT recipients and cancer patients may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related bacterial infections.
PRIMARY OBJECTIVES:
To evaluate adherence to oral hygiene by using daily compliance logs and to evaluate the efficacy of Livionex® as compared to standard toothpaste PreviDent® 5000 plus in plaque and gingivitis reduction in HSCT recipients and children receiving chemo/radiation therapy for cancer treatment.
STUDY DURATION:
Therapy 7 days and follow-ups is up to 44 days. It will take 36 months to enroll patients and complete follow-up.
SAFETY ASSESSMENTS:
The incidence of bacteremia with oral pathogens will be followed up to 44 days after first day of intervention. The investigators anticipate that the risk of bacteremia caused by oral pathogens will decrease with study procedures; however, if significantly increased incidence of bacteremia with oral pathogens is documented in either cases or controls, the study will be stopped.
EFFICACY:
The investigators will measure adherence to the protocol of teeth brushing twice per day using test and control dentifrice. The investigators will evaluate the change in dental plaque scores and gingival inflammation from day 0 to 14, and 44 for each patient, as well as compare plaque scores and gingival inflammation between the test and control groups.
At baseline, day 14, and day 44, optical coherence tomography will be used to image and thereby quantify plaque presence. Also, plaque staining will be performed and standardized photographs taken to allow for plaque distribution mapping. On these same days, saliva/dental plaque, stool and blood specimens will be collected to assess for full bacterial profile (microbiome).
UNIQUE ASPECTS:
This study uses a new dentifrice that has been shown to improve plaque control in pediatric cancer patients and HSCT recipients with the goal of improving plaque control during HSCT. This is the first study exploring the composition of plaque and oral microbiome in pediatric HSCT recipients. This study will gather data on the possible link between the oral and gut microbiome with systemic bacteremia during HSCT, the effect of plaque reduction on oral microbiome, and the effect of systemic antibiotic use on oral microbiome.
- Conditions
- Dental Plaque
- Being tested
- Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste, Kolibree Toothbrush
- Keywords
- Dental Plaque, Gingivitis, Bacterial Infection, Oral Hygiene, HSCT, Oral Microbiome, Gut Microbiome, Blood Microbiome
- Medical subject headings
- Dental Plaque, Gingivitis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livionex® Dental GelDrug
Also called Edathamil
Oral application Dental Plaque, Gingivitis and Oral Microbiome Control.
PreviDent 5000 plus/Tom's of Maine Children's toothpasteDrug
Also called Over the counter toothpaste
Oral application for Dental Plaque, Gingivitis and Oral Microbiome Control.
Kolibree ToothbrushDevice
Electric Toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Livionex® Dental Gel | Experimental | Study patients assigned to this arm will use Livionex toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment. Receives: Drug: Livionex® Dental Gel; Device: Kolibree Toothbrush |
| PreviDent 5000 plus/Tom's of Maine Children's toothpaste | Active comparator | Study patients assigned to this arm will use PreviDent 5000 plus or Tom's of Maine Children's (age 6 years and younger) toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment. Receives: Drug: PreviDent 5000 plus/Tom's of Maine Children's toothpaste; Device: Kolibree Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to oral hygiene
Compliance will be recorded two times daily, units on a scale 0 - 2 (2 = excellent compliance, 0 = no compliance). A mean score from day 1 to 7 will be compared (t-test) for each patient and between the treatment and the control group.
Measured: 7 days
Plaque index score (Shick R.A., 1961)
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = absence of dental plaque on the gingival half of the facial surface of a tooth, 1 = the presence of dental plaque covering less than 1/3 of the gingival half of the farcical surface, 2 = the presence of dental plaque covering 1/3 or less than 2/3 of the gingival half of the facial surface, 3 = the presence of dental plaque covering 2/3 or more of the facial surface). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Measured: 0 to 44 days - change from baseline to day 14 and 44 will be measured
Gingival index score (Löe H, 1967)
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = Normal gingiva, 1 = Mild inflammation -- slight change in color, slight edema. No bleeding on probing, 2 = Moderate inflammation-redness, edema and glazing. Bleeding on probing, 3 = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Measured: 0 to 44 days - change from baseline to day 14 and 44 will be measured
Optical Coherence Tomography (OCT) score (Turesky modification of the Quigley-Hein Plaque Index, Ajaharain J, 2014)
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 5 (0 = No plaque, 1 = Separate flecks of plaque at the cervical margin, 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth, 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth, 5 = Plaque covering 2/3 or more of the side of the crown of the tooth). A mean score of each time point (day 0, 7, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Measured: 0 to 44 days - change from baseline to day 14 and 44 will be measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start28 Jul 2016
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Den Besten, DDS, MS, Principal investigator, School of Dentistry, UC San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617407
- Sponsor's protocol ID
- 15-18297
- Other IDs
- NCI-2019-00244, 160814
- Status last verified
- Sep 2024
- First submitted
- 6 Nov 2015
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study -- Oral Microbiome and Dental Plaque Control With Livionex(R) in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT02617407
- Acronym / sponsor ID
- 15-18297
- Conditions
- Dental Plaque
- Keywords
- Dental Plaque, Gingivitis, Bacterial Infection, Oral Hygiene, HSCT, Oral Microbiome, Gut Microbiome, Blood Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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.
Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in reducing dental plaques while containing no additives found in other toothpastes that can cause increased gingival irritation. The investigators hypothesize that improved oral hygiene and better plaque control in pediatric patients receiving chemo/radiation treatment or HSCT may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot study is to determine whether incorporation of the Livionex® toothpaste in the research regimen could reduce dental plaque.
Detailed description
This is a prospective randomized (2:1) pilot study of children undergoing HSCT or chemo/radiation therapy for cancer treatment who are able to cooperate with saliva collection and dental exams.
RATIONALE:
As chemotherapy and radiation therapy result in a break-down of the mucosal barrier, HSCT recipients and cancer patients are at a significant risk for bacteremia and sepsis from oral pathogens. Children undergoing HSCT have significant difficulties achieving good oral hygiene and dental plaque control because of sensitivity of oral tissues leading to intolerance of teeth brushing and standard dentifrice. This usually results in plaque buildup and moderate to severe gingival inflammation, which persists during and after transplantation. The investigators hypothesize that improved oral hygiene and better plaque control in HSCT recipients and cancer patients may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related bacterial infections.
PRIMARY OBJECTIVES:
To evaluate adherence to oral hygiene by using daily compliance logs and to evaluate the efficacy of Livionex® as compared to standard toothpaste PreviDent® 5000 plus in plaque and gingivitis reduction in HSCT recipients and children receiving chemo/radiation therapy for cancer treatment.
STUDY DURATION:
Therapy 7 days and follow-ups is up to 44 days. It will take 36 months to enroll patients and complete follow-up.
SAFETY ASSESSMENTS:
The incidence of bacteremia with oral pathogens will be followed up to 44 days after first day of intervention. The investigators anticipate that the risk of bacteremia caused by oral pathogens will decrease with study procedures; however, if significantly increased incidence of bacteremia with oral pathogens is documented in either cases or controls, the study will be stopped.
EFFICACY:
The investigators will measure adherence to the protocol of teeth brushing twice per day using test and control dentifrice. The investigators will evaluate the change in dental plaque scores and gingival inflammation from day 0 to 14, and 44 for each patient, as well as compare plaque scores and gingival inflammation between the test and control groups.
At baseline, day 14, and day 44, optical coherence tomography will be used to image and thereby quantify plaque presence. Also, plaque staining will be performed and standardized photographs taken to allow for plaque distribution mapping. On these same days, saliva/dental plaque, stool and blood specimens will be collected to assess for full bacterial profile (microbiome).
UNIQUE ASPECTS:
This study uses a new dentifrice that has been shown to improve plaque control in pediatric cancer patients and HSCT recipients with the goal of improving plaque control during HSCT. This is the first study exploring the composition of plaque and oral microbiome in pediatric HSCT recipients. This study will gather data on the possible link between the oral and gut microbiome with systemic bacteremia during HSCT, the effect of plaque reduction on oral microbiome, and the effect of systemic antibiotic use on oral microbiome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Livionex® Dental Gel | Experimental | Drug: Livionex® Dental Gel, Device: Kolibree ToothbrushStudy patients assigned to this arm will use Livionex toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment. |
| PreviDent 5000 plus/Tom's of Maine Children's toothpaste | Active comparator | Drug: PreviDent 5000 plus/Tom's of Maine Children's toothpaste, Device: Kolibree ToothbrushStudy patients assigned to this arm will use PreviDent 5000 plus or Tom's of Maine Children's (age 6 years and younger) toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HSCT recipient or chemo/radiation therapy patients who can cooperate with study procedures.
- Parents and patient willing to participate and sign informed consent and assent forms.
Key exclusion criteria (2 listed)
- Unable to understand or participate in study procedures.
- Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.
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 |
|---|---|---|
| Livionex® Dental GelAlso: EdathamilOral application Dental Plaque, Gingivitis and Oral Microbiome Control. | Drug | Livionex® Dental Gel |
| PreviDent 5000 plus/Tom's of Maine Children's toothpasteAlso: Over the counter toothpasteOral application for Dental Plaque, Gingivitis and Oral Microbiome Control. | Drug | PreviDent 5000 plus/Tom's of Maine Children's toothpaste |
| Kolibree ToothbrushElectric Toothbrush | Device | Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste |
Primary outcome
Adherence to oral hygiene
Time frame: 7 days
Compliance will be recorded two times daily, units on a scale 0 - 2 (2 = excellent compliance, 0 = no compliance). A mean score from day 1 to 7 will be compared (t-test) for each patient and between the treatment and the control group.
Plaque index score (Shick R.A., 1961)
Time frame: 0 to 44 days - change from baseline to day 14 and 44 will be measured
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = absence of dental plaque on the gingival half of the facial surface of a tooth, 1 = the presence of dental plaque covering less than 1/3 of the gingival half of the farcical surface, 2 = the presence of dental plaque covering 1/3 or less than 2/3 of the gingival half of the facial surface, 3 = the presence of dental plaque covering 2/3 or more of the facial surface). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Gingival index score (Löe H, 1967)
Time frame: 0 to 44 days - change from baseline to day 14 and 44 will be measured
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = Normal gingiva, 1 = Mild inflammation -- slight change in color, slight edema. No bleeding on probing, 2 = Moderate inflammation-redness, edema and glazing. Bleeding on probing, 3 = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Optical Coherence Tomography (OCT) score (Turesky modification of the Quigley-Hein Plaque Index, Ajaharain J, 2014)
Time frame: 0 to 44 days - change from baseline to day 14 and 44 will be measured
The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 5 (0 = No plaque, 1 = Separate flecks of plaque at the cervical margin, 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth, 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth, 5 = Plaque covering 2/3 or more of the side of the crown of the tooth). A mean score of each time point (day 0, 7, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pamela Den Besten, DDS, MS principal investigator
School of Dentistry, UC San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste and Kolibree Toothbrush in people with Dental Plaque, run by University of California, San Francisco 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 23 Sep 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to oral hygiene (time frame: 7 days). The study lists 4 primary outcomes in all. 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 23 Sep 2024.