NCT03143023

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 4, 2017

Last Update Submit

May 6, 2017

Conditions

Outcome Measures

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.

    10 minutes after intervention and control

Study Arms (2)

arginine toothpaste

EXPERIMENTAL
Drug: arginine toothpaste

fluoride toothpaste

ACTIVE COMPARATOR
Drug: fluoride toothpaste

Interventions

acid neutralizer toothpaste

arginine toothpaste

bactericidal toothpaste

fluoride toothpaste

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

laura yehia zanati, master

CONTACT

aya mohamed adly, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university,2013

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

May 9, 2017

Record last verified: 2017-05