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
About this trial
This is an interventional prevention trial for Dental Caries
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
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
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
background
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Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
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