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

NCT04998617 | Completed

• 1 other identifier: 20-3428
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Toothpaste Containing Curcumin

EXPERIMENTAL

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

Other: Toothpaste with curcumin

Toothpaste Without Curcumin

PLACEBO COMPARATOR

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

Other: Toothpaste without curcumin

Interventions

Toothpaste with curcumin OTHER

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

Toothpaste Containing Curcumin

Toothpaste without curcumin OTHER

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

Toothpaste Without Curcumin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Colgate Palmolive: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Halitosis

Interventions

Toothpastes; Curcumin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Antonio Moretti, DDS, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 10, 2021
• Study Start: May 24, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)