Skip to main content
OpenTrials
Completed

NCT Number: NCT04998617

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toothpaste with curcumin

Other

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

Toothpaste without curcumin

Other

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Colgate Palmolive

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.