Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients

Risk Reduction Clinical Trial

Official title:

Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03222960
• Other study ID #: CEBC-CU-2017-07-26
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 24, 2017
• Start date: October 2017
• Est. completion date: April 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.

Description:

A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.

Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:

1. 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles

2. The upper and lower teeth will be brushed for 2 min;

3. After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry

4. No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants should be over 18 years of age.

• Participants should be high caries risk.

• Systematically healthy.

• Not taking any medication interfering with saliva secretion.

• Participants who signed informed consent.

Exclusion criteria:

• Participants with a compromised medical history.

• Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.

• Severe or active periodontal disease.

• History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.

Related Conditions & MeSH terms

• Risk Reduction

Intervention

Drug:
• propolis-containing toothpaste
participants will use propolis-containing toothpaste for 6 months
• Fluoride-containing toothpaste
participants will use Fluoride-containing toothpaste for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving caries risk	caries risk assessment	6 months