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

University of North Carolina (UNC)

Status: Completed

Conditions: Halitosis

Treatments: Other: Toothpaste with curcumin; Other: Toothpaste without curcumin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04998617

20-3428

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Toothpaste Containing Curcumin

Experimental group

Description:

After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.

Treatment:

Other: Toothpaste with curcumin

Toothpaste Without Curcumin

Placebo Comparator group

Description:

After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.

Treatment:

Other: Toothpaste without curcumin