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Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Xylitol
xylitol with bicarbonate
paraffin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients eligible for the trial must comply with all of the following at randomization.

    1. Age range from 20-50 years
    2. High caries risk patients defined according to American Dental Association (ADA)
    3. Acidic baseline saliva pH
    4. Systematically healthy
    5. Not taking any medication interfering with saliva secretion
    6. Subjects who signed informed consent

Exclusion Criteria:

  • (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients

Sites / Locations

  • Howaida Fakhry Fouad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

xylitol chewing gum

xylitol with bicarbonate chewing gum

Paraffin pellet

Arm Description

intervention

intervention

comparator

Outcomes

Primary Outcome Measures

Salivary pH change
will be done by digital pH meter

Secondary Outcome Measures

Full Information

First Posted
February 19, 2017
Last Updated
February 22, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03061422
Brief Title
Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
Official Title
Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2017 (Anticipated)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am). Direct benefit of the research to the human volunteer: It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost. Scientific value and social benefits: This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods. Expected risk to the human subjects: Allergic reactions due to any of the components of the materials used which is rare to occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
xylitol chewing gum
Arm Type
Experimental
Arm Description
intervention
Arm Title
xylitol with bicarbonate chewing gum
Arm Type
Experimental
Arm Description
intervention
Arm Title
Paraffin pellet
Arm Type
Active Comparator
Arm Description
comparator
Intervention Type
Other
Intervention Name(s)
Xylitol
Intervention Description
caries prevention chewing gum
Intervention Type
Other
Intervention Name(s)
xylitol with bicarbonate
Intervention Description
caries prevention chewing gum
Intervention Type
Other
Intervention Name(s)
paraffin
Intervention Description
chewing gum
Primary Outcome Measure Information:
Title
Salivary pH change
Description
will be done by digital pH meter
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients eligible for the trial must comply with all of the following at randomization. Age range from 20-50 years High caries risk patients defined according to American Dental Association (ADA) Acidic baseline saliva pH Systematically healthy Not taking any medication interfering with saliva secretion Subjects who signed informed consent Exclusion Criteria: (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
howaida f. Fouad, master
Email
howaidafakhry@gmail.com
Facility Information:
Facility Name
Howaida Fakhry Fouad
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
howaida f. fouad, master

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27274153
Citation
Ballal RK, Bhat SS, Ramdas SS, Ballal S. Effect of Chewing Bicarbonate-containing Sugar-free Gum on the Salivary pH: An in vivo Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):35-8. doi: 10.5005/jp-journals-10005-1330. Epub 2016 Apr 22.
Results Reference
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Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH

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