Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count

July 27, 2017 updated by: Neven Ahmed Ebrahim, Cairo University

Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count :Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Neven Ahmed Ebrahim, master
  • Phone Number: 01153621944
  • Email: nova480@yahoo.com

Study Contact Backup

Study Locations

  • Egypt
    • Heliopolis
      • Cairo, Heliopolis, Egypt, 11311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: aloe vera toothpaste
aloe vera toothpaste isa will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
Drug: aloe vera toothpaste
herbal toothpaste used to decrease salivary streptococcus bacterial count
Other Names:
  • aloe dent toothpaste
  • aloe dent
ACTIVE_COMPARATOR: fluoride toothpaste
fluoride toothpaste isa herbal toothpaste will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days
Drug: fluoride toothpaste
chemical toothpaste used to decrease salivary streptococcus bacterial count
Other Names:
  • signal toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary bacterial count
Time Frame: average of 30 days
will be done using mitis salivarius agar plate
average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Amira Farid, PHD, professor at conservative department cairo university
  • Study Chair: Rasha Rafaat, PHD, lecturer at conservative department cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2017

Primary Completion (ANTICIPATED)

April 30, 2018

Study Completion (ANTICIPATED)

April 30, 2018

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (ACTUAL)

April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-30-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publishing the data at egyptian dental journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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