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Status unknownNCT03143023Updated May 9, 2017

Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid

An interventional study of arginine toothpaste and fluoride toothpaste in Dental Caries, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.

Read the detailed description

.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 28 is below the median of 60 across 915 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants should be over 18 years of age.
  • Systematically healthy.
  • Not taking any medication interfering with saliva secretion.
  • Participants who signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Participants with a compromised medical history.
  • Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
  • Severe or active periodontal disease.
  • History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    arginine toothpaste

    Drug: arginine toothpaste

  • Active comparator
    fluoride toothpaste

    Drug: fluoride toothpaste

Interventions

  • Drugarginine toothpaste

    acid neutralizer toothpaste

  • Drugfluoride toothpaste

    bactericidal toothpaste

06

What researchers measure

Primary outcomes

  1. salivary pH

    Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed "resting pH," while the salivary pH values measured after usage of toothpaste termed "terminal pH.

    Time frame: 10 minutes after intervention and control

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03143023
Lead sponsor
Cairo University
Responsible party
Laura Yehia (Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university,2013, Cairo University) — Principal investigator
First posted
May 8, 2017
Start date
Jun 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
May 9, 2017

Study contacts

laura yehia zanati, master
Contact
laura_lola92@yahoo.com
01204470007
aya mohamed adly, master
Contact
adly_sweetdentist@hotmail.com
012215228843

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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