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NCT04998617 · ClinicalTrials.gov registry record · NA

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

A NA study of Halitosis, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT04998617: Completed NA study of Halitosis, sponsored by University of North Carolina, Chapel Hill.

NCT04998617 is a NA study of Halitosis that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 30 participants, below the 49-participant average among 3 other Halitosis trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04998617, a NA study of Halitosis, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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).

Conditions Studied

Interventions

  • OTHER Toothpaste with curcumin
  • OTHER Toothpaste without curcumin

Study Locations (1)

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-05-24
Est. Completion 2023-05-05
Phase NA

What the finished NCT04998617 record still lists

NCT04998617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 49-participant average among 3 other Halitosis trials with a reported enrollment target (39% lower).

The record links to 1 condition, with Halitosis appearing as the primary indexed condition, and to 2 interventions - of which Toothpaste with curcumin is the first listed.

NCT04998617 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT04998617 about?

NCT04998617 is a clinical study titled "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 ...

What is the current status of trial NCT04998617?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-05-24. Estimated completion is 2023-05-05.

What conditions does trial NCT04998617 study?

This clinical trial studies the following conditions: Halitosis.

What interventions are being tested in trial NCT04998617?

The interventions under investigation include: Toothpaste with curcumin (OTHER), Toothpaste without curcumin (OTHER).

Who is sponsoring clinical trial NCT04998617?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04998617 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04998617, the US trial registry maintained by the National Library of Medicine. NCT04998617 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.