Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis

Conditions
-----------------
Halitosis

Intervention / Treatment
-----------------
* Other: Toothpaste with curcumin
* Other: Toothpaste without curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toothpaste Containing Curcumin<br>After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin. | Other: Toothpaste with curcumin<br>* Subjects will be given toothpaste to be used during this study with 0.5% curcumin<br>|
| Placebo Comparator: Toothpaste Without Curcumin<br>After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin. | Other: Toothpaste without curcumin<br>* Subjects will be given toothpaste to be used during this study without curcumin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | baseline, 21 days |