Clinical trial NCT04998617: Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
Official title: Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2021-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Volatile Sulphur Compounds (VSC) at day 7
timeFrame: day 7
measure: Volatile Sulphur Compounds (VSC) at day 14
timeFrame: day 14
measure: Volatile Sulphur Compounds (VSC) at day 21
timeFrame: day 21
measure: Repeated Measures Regression of Volatile Sulphur Compounds (VSC)
timeFrame: baseline, 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Antonio Moretti, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: