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

NCT ID: NCT04998617

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2023-05-05

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.

Conditions

Halitosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Toothpaste Containing Curcumin

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

Group Type: EXPERIMENTAL

Toothpaste with curcumin

Intervention Type: OTHER

Subjects will be given toothpaste to be used during this study with 0.5% curcumin

Toothpaste Without Curcumin

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

Group Type: PLACEBO_COMPARATOR

Toothpaste without curcumin

Intervention Type: OTHER

Subjects will be given toothpaste to be used during this study without curcumin

Interventions

Toothpaste with curcumin

Subjects will be given toothpaste to be used during this study with 0.5% curcumin

Intervention Type: OTHER

Toothpaste without curcumin

Subjects will be given toothpaste to be used during this study without curcumin

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Moretti, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

20-3428

Identifier Type: -

Identifier Source: org_study_id