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

Not Applicable

Completed

• Conditions: Halitosis
• Interventions: Other: Toothpaste with curcumin; Other: Toothpaste without curcumin

• Registration Number: NCT04998617
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-10
• Study Start: 2022-05-24
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toothpaste Containing Curcumin	Toothpaste with curcumin	After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.
Toothpaste Without Curcumin	Toothpaste without curcumin	After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.

Primary Outcome Measures

Name	Time	Method
Volatile Sulphur Compounds (VSC) at day 7	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 21	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)	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.
Volatile Sulphur Compounds (VSC) at day 14	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).

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States