HalitosisNCT04998617
Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
A study testing Toothpaste with curcumin and Toothpaste without curcumin in people with Halitosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To investigate the short-term clinical effect of curcumin-containing toothpaste on halitosis as compared to placebo and to assess potential shifts in the composition of dental biofilm associated with the use of curcumin-containing toothpaste Participants: This clinical study will 30 adult participants under… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Halitosis
- What is being tested?
- Toothpaste with curcumin and Toothpaste without curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 5 May 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be adult males or females between the ages of 18 and 65 years (inclusive) reporting halitosis
- Participants must be able and willing to follow study procedures and instructions
- Participants must have read, understood and signed an informed consent form
- Participants must present with at least 8 teeth in the functional dentition and with at least 4 teeth in each posterior sextant, 3 of which are adjacent teeth with interproximal papilla in each posterior sextant that will have the stent
- Participants must be in good general health
Who cannot join
- Patients ongoing restorative or periodontal dental treatment or any other medical treatment
- Subjects with any pathological alterations of the oral mucosa
- Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
- Pregnant women
- Subjects with untreated periodontitis or active caries lesion
- Subjects diagnosed with acute sinusitis, bronchitis or tonsillitis
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- Subjects under treatment on medications which can cause malodor, e.g. amphetamines, nitrates and nitrites
- Known diabetes, liver or kidney insufficiency
- Subjects diagnosed with reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
- Subjects who underwent preventive periodontal treatment, i.e. oral prophylaxis treatment, within the last week
- Volunteers unwilling to abstain from additional oral hygiene (only tooth brushing allowed) particularly mouthrinse, chewing gums, breath strips, etc and alcohol 12 h prior the first measurement at the study site and until the completion of all measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Purpose: To investigate the short-term clinical effect of curcumin-containing toothpaste on halitosis as compared to placebo and to assess potential shifts in the composition of dental biofilm associated with the use of curcumin-containing toothpaste
Participants: This clinical study will 30 adult participants under prophylactic or periodontal maintenance protocol.
Procedures (methods): Participants will be included and throughout the protocol will not allow the use any other oral hygiene products except standard manual toothbrush and study toothpaste (either test -curcumin-containing or placebo). Additionally participants will be instructed to odiferous foods such as onions, garlic and spices. At each of the three examination sessions, Plaque Index (six sites, O'Leary) and volatile sulphur compounds (VSC) will be measured.
- Conditions
- Halitosis
- Being tested
- Toothpaste with curcumin, Toothpaste without curcumin
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste with curcuminOther
Subjects will be given toothpaste to be used during this study with 0.5% curcumin
Toothpaste without curcuminOther
Subjects will be given toothpaste to be used during this study without curcumin
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste Containing Curcumin | Experimental | After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin. Receives: Other: Toothpaste with curcumin |
| Toothpaste Without Curcumin | Placebo comparator | After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin. Receives: Other: Toothpaste without curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile Sulphur Compounds (VSC) at day 7
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Measured: day 7
Volatile Sulphur Compounds (VSC) at day 14
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Measured: day 14
Volatile Sulphur Compounds (VSC) at day 21
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Measured: day 21
Repeated Measures Regression of Volatile Sulphur Compounds (VSC)
A repeated measures regression with VSC as the response and treatment (curcumin or negative control) and time (7, 14 or 21 days) as predictors. An autoregressive correlation matrix will be used to account for the correlation between repeated measures within subject.
Measured: baseline, 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start24 May 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Antonio Moretti, DDS, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998617
- Sponsor's protocol ID
- 20-3428
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
- ClinicalTrials.gov ID
- NCT04998617
- Acronym / sponsor ID
- 20-3428
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 24 May 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 10 Aug 2021 (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.
Purpose: To investigate the short-term clinical effect of curcumin-containing toothpaste on halitosis as compared to placebo and to assess potential shifts in the composition of dental biofilm associated with the use of curcumin-containing toothpaste
Participants: This clinical study will 30 adult participants under prophylactic or periodontal maintenance protocol.
Procedures (methods): Participants will be included and throughout the protocol will not allow the use any other oral hygiene products except standard manual toothbrush and study toothpaste (either test -curcumin-containing or placebo). Additionally participants will be instructed to odiferous foods such as onions, garlic and spices. At each of the three examination sessions, Plaque Index (six sites, O'Leary) and volatile sulphur compounds (VSC) will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste Containing Curcumin | Experimental | Other: Toothpaste with curcuminAfter screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin. |
| Toothpaste Without Curcumin | Placebo comparator | Other: Toothpaste without curcuminAfter screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be adult males or females between the ages of 18 and 65 years (inclusive) reporting halitosis
- Participants must be able and willing to follow study procedures and instructions
- Participants must have read, understood and signed an informed consent form
- Participants must present with at least 8 teeth in the functional dentition and with at least 4 teeth in each posterior sextant, 3 of which are adjacent teeth with interproximal papilla in each posterior sextant that will have the stent
- Participants must be in good general health
Key exclusion criteria (11 listed)
- Patients ongoing restorative or periodontal dental treatment or any other medical treatment
- Subjects with any pathological alterations of the oral mucosa
- Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
- Pregnant women
- Subjects with untreated periodontitis or active caries lesion
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 |
|---|---|---|
| Toothpaste with curcuminSubjects will be given toothpaste to be used during this study with 0.5% curcumin | Other | Toothpaste Containing Curcumin |
| Toothpaste without curcuminSubjects will be given toothpaste to be used during this study without curcumin | Other | Toothpaste Without Curcumin |
Primary outcome
Volatile Sulphur Compounds (VSC) at day 7
Time frame: day 7
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Volatile Sulphur Compounds (VSC) at day 14
Time frame: day 14
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Volatile Sulphur Compounds (VSC) at day 21
Time frame: day 21
Volatile Sulphur Compounds (VSC) values for all subjects will be recorded. F-tests will be used to compare the curcumin group with the placebo group at each timepoint. P-values less than 0.05 will be considered statistically significant. Analyses will be performed using SAS Version 9.4 (SAS Institute, Cary NC).
Repeated Measures Regression of Volatile Sulphur Compounds (VSC)
Time frame: baseline, 21 days
A repeated measures regression with VSC as the response and treatment (curcumin or negative control) and time (7, 14 or 21 days) as predictors. An autoregressive correlation matrix will be used to account for the correlation between repeated measures within subject.
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 9 Aug 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Antonio Moretti, DDS, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste with curcumin and Toothpaste without curcumin in people with Halitosis, run by University of North Carolina, Chapel Hill 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 5 inclusion and 11 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 9 Aug 2023. 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?
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?
Volatile Sulphur Compounds (VSC) at day 7 (time frame: day 7). 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 9 Aug 2023.