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

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toothpaste with curcumin
Toothpaste without curcumin
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Toothpaste Containing Curcumin

Toothpaste Without Curcumin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2021
Last Updated
August 8, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT04998617
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toothpaste Containing Curcumin
Arm Type
Experimental
Arm Description
After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.
Arm Title
Toothpaste Without Curcumin
Arm Type
Placebo Comparator
Arm Description
After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.
Intervention Type
Other
Intervention Name(s)
Toothpaste with curcumin
Intervention Description
Subjects will be given toothpaste to be used during this study with 0.5% curcumin
Intervention Type
Other
Intervention Name(s)
Toothpaste without curcumin
Intervention Description
Subjects will be given toothpaste to be used during this study without curcumin
Primary Outcome Measure Information:
Title
Volatile Sulphur Compounds (VSC) at day 7
Description
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).
Time Frame
day 7
Title
Volatile Sulphur Compounds (VSC) at day 14
Description
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).
Time Frame
day 14
Title
Volatile Sulphur Compounds (VSC) at day 21
Description
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).
Time Frame
day 21
Title
Repeated Measures Regression of Volatile Sulphur Compounds (VSC)
Description
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.
Time Frame
baseline, 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Moretti, DDS, MS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing 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.

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

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