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

NCT03108313 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CEBC-CU-2017-30-16
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

• salivary bacterial count

  will be done using mitis salivarius agar plate

  average of 30 days

Study Arms (2)

aloe vera toothpaste

EXPERIMENTAL

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

fluoride toothpaste

ACTIVE COMPARATOR

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

Interventions

aloe vera toothpaste DRUG

herbal toothpaste used to decrease salivary streptococcus bacterial count

Also known as: aloe dent toothpaste, aloe dent

aloe vera toothpaste

fluoride toothpaste DRUG

chemical toothpaste used to decrease salivary streptococcus bacterial count

Also known as: signal toothpaste

fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have poor oral hygiene.
• Patients should have high bacterial count

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Neven Ahmed Ebrahim

Cairo, Heliopolis, 11311, Egypt

RECRUITING

Related 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.

  PMID: 26539392 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Amira Farid, PHD

  professor at conservative department cairo university

  STUDY DIRECTOR

• Rasha Rafaat, PHD

  lecturer at conservative department cairo university

  STUDY CHAIR

Central Study Contacts

Neven Ahmed Ebrahim, master

CONTACT

01153621944; nova480@yahoo.com

Neven Ahmed Ebrahim, master

CONTACT

01005475566; Dr.mohamedsabry90@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, resident at conservative department

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 11, 2017
• Study Start: March 3, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)