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

Dental Caries Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03061422
• Other study ID #: CEBC-CU-2017-02-14
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2017
• Last updated: February 22, 2017
• Start date: March 3, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: howaida f. Fouad, master
• Email: howaidafakhry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: November 30, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Xylitol
caries prevention chewing gum
• xylitol with bicarbonate
caries prevention chewing gum
• paraffin
chewing gum

Locations

Country	Name	City	State
Egypt	Howaida Fakhry Fouad	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary pH change	will be done by digital pH meter	an average of 1 year