Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
1 active site
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
February 19, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedFebruary 24, 2017
February 1, 2017
7 months
February 19, 2017
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Salivary pH change
will be done by digital pH meter
an average of 1 year
Study Arms (3)
xylitol chewing gum
EXPERIMENTALintervention
xylitol with bicarbonate chewing gum
EXPERIMENTALintervention
Paraffin pellet
ACTIVE COMPARATORcomparator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Howaida Fakhry Fouad
Giza, Egypt
Related Publications (1)
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.
PMID: 27274153BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 2012
Study Record Dates
First Submitted
February 19, 2017
First Posted
February 23, 2017
Study Start
March 3, 2017
Primary Completion
October 1, 2017
Study Completion
November 30, 2018
Last Updated
February 24, 2017
Record last verified: 2017-02