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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108313
Enrollment
58
Registered
2017-04-11
Start date
2017-03-03
Completion date
2018-04-30
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental

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.

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.

Interventions

herbal toothpaste used to decrease salivary streptococcus bacterial count

DRUGfluoride toothpaste

chemical toothpaste used to decrease salivary streptococcus bacterial count

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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 .

Design outcomes

Primary

MeasureTime frameDescription
salivary bacterial countaverage of 30 dayswill be done using mitis salivarius agar plate

Countries

Egypt

Contacts

Primary ContactNeven Ahmed Ebrahim, master
nova480@yahoo.com01153621944
Backup ContactNeven Ahmed Ebrahim, master
Dr.mohamedsabry90@yahoo.com01005475566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026