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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03108313

Collaborator

(none)

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental	Drug: aloe vera toothpaste Drug: fluoride toothpaste	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 3, 2017

Anticipated Primary Completion Date :

Apr 30, 2018

Anticipated Study Completion Date :

Apr 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

salivary bacterial count [average of 30 days]
will be done using mitis salivarius agar plate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neven Ahmed Ebrahim	Cairo	Heliopolis	Egypt	11311

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Neven Ahmed Ebrahim, principal investigator, resident at conservative department, Cairo University

ClinicalTrials.gov Identifier:

NCT03108313

Other Study ID Numbers:

CEBC-CU-2017-30-16

First Posted:

Apr 11, 2017

Last Update Posted:

Jul 31, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dental Caries

Fluorides

Study Results

No Results Posted as of Jul 31, 2017