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

Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061422
Enrollment
36
Registered
2017-02-23
Start date
2017-03-03
Completion date
2018-11-30
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

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.

Interventions

OTHERXylitol

caries prevention chewing gum

OTHERxylitol with bicarbonate

caries prevention chewing gum

chewing gum

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary pH changean average of 1 yearwill be done by digital pH meter

Countries

Egypt

Contacts

Primary Contacthowaida f. Fouad, master
howaidafakhry@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026