- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998617
Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antonio Moretti, DDS, MS
- Phone Number: 919-537-3727
- Email: antonio_moretti@dentistry.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Toothpaste Containing Curcumin
After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.
|
Subjects will be given toothpaste to be used during this study with 0.5% curcumin
|
Placebo Comparator: Toothpaste Without Curcumin
After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.
|
Subjects will be given toothpaste to be used during this study without curcumin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
day 7
|
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).
|
day 14
|
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).
|
day 21
|
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.
|
baseline, 21 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Antonio Moretti, DDS, MS, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Halitosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 20-3428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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