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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03108313
Other study ID # CEBC-CU-2017-30-16
Secondary ID
Status Recruiting
Phase Phase 2
First received March 29, 2017
Last updated July 27, 2017
Start date March 3, 2017
Est. completion date April 30, 2018

Study information

Verified date July 2017
Source Cairo University
Contact Neven Ahmed Ebrahim, master
Phone 01153621944
Email nova480@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.


Description:

Variables of study:

Each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste

Outcomes:

Salivary bacterial count will be evaluated using Mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days .

Participant timeline:

Enrolment Baseline assessment 15 days 30 days

(1st visit ) (2nd visit) (3rd visit )

II.6.Sample size calculation :

Based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I probability associated with this test of this null hypothesis is 0.05.

Recruitment & Recruitment Strategy:

Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. Randomization and assignment of interventions:

Randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/Control assessment method

Allocation sequence generation:

The allocation sequence will be generated using (www.randomization.com).

Allocation concealment mechanism:

A checklist will be designed to identify each assessment method.

Implementation A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures to respective teeth.

Blinding:

The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.

Data collection methods:

High caries index will be assessed 3 times , at base line , then 15 days and 30 days.

Funding:

The research will be self-funded by the researcher.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients should have poor oral hygiene.

- Patients should have high bacterial count

Exclusion Criteria:

- Patients with a compromised medical history.

- Severe or active periodontal disease .

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
aloe vera toothpaste
herbal toothpaste used to decrease salivary streptococcus bacterial count
fluoride toothpaste
chemical toothpaste used to decrease salivary streptococcus bacterial count

Locations

Country Name City State
Egypt Neven Ahmed Ebrahim Cairo Heliopolis

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Bhati N, Jaidka S, Somani R. Evaluation of antimicrobial efficacy of Aloe vera and Meswak containing dentifrices with fluoridated dentifrice: An in vivo study. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):394-9. doi: 10.4103/2231-0762.165924. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary salivary bacterial count will be done using mitis salivarius agar plate average of 30 days
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