An interventional study of Toothpaste with curcumin and Toothpaste without curcumin in Halitosis, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria
After screening, participants will be randomly assigned to receive toothpaste that contains 0.5% curcumin.
Other: Toothpaste with curcumin
After screening, participants will be randomly assigned to receive toothpaste that does not contain curcumin.
Other: Toothpaste without curcumin
Subjects will be given toothpaste to be used during this study with 0.5% curcumin
Subjects will be given toothpaste to be used during this study without curcumin
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: baseline, 21 days
Plan to share: Yes — 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.
Supporting information: Study protocol
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill