Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Volatile Sulphur Compounds (VSC) at day 7
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Toothpaste Containing Curcumin
After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.
Intervention: Toothpaste with curcumin (Other)
Toothpaste Without Curcumin
After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.
Intervention: Toothpaste without curcumin (Other)
Outcomes
Primary Outcomes
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 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.
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).
Secondary Outcomes
No secondary outcomes reported