- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662385
The Effect of Toothpaste Containing Aloe Vera on Gingivitis
The Effect of Toothpaste Containing Aloe Vera on Clinical and Microbiological Out Comes With Measuring IL_1 β in Gingival Crevicular Fluid: a Randomized Controlled Crossover Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the most predominant periodontal diseases is the plaque induced gingivitis. Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects.
Aim: The aim of study is to evaluate the toothpaste containing high concentration of Aloe Vera on reduction of plaque and gingivitis and on clinical periodontal parameter (PI&BOP) salivary primary colonizers boat (S. sanguinis and S. mutant).and determine the effect of aloe vera toothpaste on the pro inflammatory cytokines (IL_1β) in the gingival crevicular fluid.
Objective To evaluate the efficacy of aloe vera toothpaste on IL_1β by using ELISA technique and evaluate the efficacy of aloe vera toothpaste on early colonizer load using (PCR).
Null hypothesis aloe vera has Anti-Inflammatory effect by reducing IL_1β and some clinical periodontal parameters (plaque index& bleeding on probing index) when used by the patients with regular mechanical oral hygiene.
Alternative hypothesis the effect of aloe vera toothpaste is less than Colgate toothpaste on the inflammatory marker IL_1β, early load and some clinical parameters (PI and BOP).
Materials and methods Twenty-four adult patients (male and female) with generalized gingivitis participated in the double-blinded randomized crossover trial was divided into two groups, (aloe vera and Colgate toothpaste). A week after receiving polishing and scaling,24hours plaque re-growth. In zero day, after 24h and 7 days' time points, plaque index and bleeding on probe was recorded, and then the participants entered a 7-day washout period with regular oral hygiene measures. And 7days to used other type of toothpaste (aloe vera or Colgate).in the first visit (zero day) GCF collected from targeted sites (upper incisors, labial side). In the second visit (after 24 hours) saliva collected (for early colonizer load) and the patient brushing teeth and wait 2 hours, after 2hour saliva collected again. the GCF collected in third visit (after7 days), fourth visit (after wash out period) and fifth visit from the same teeth. Saliva collected in third and fifth visit.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Baghdad, Iraq, 10001
- Baghdad university college of dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) 20_30 years old subject. (2) good general health. (3) presence of more than 20 teeth
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Exclusion Criteria:
- active cavity caries and/or periodontal disease.
- ongoing orthodontic treatment.
- a history of antibiotics within the past 4 months.
- require prophylactic antibiotic coverage.
- require systemic and/or topical non-steroidal anti-inflammatory drugs for the past 4 months.
- pregnant or intended to and lactating mother.
- have heart valve replacement and\or any systemic disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: aloe vera toothpaste group
a recently available aloe vera toothpaste for gingival care, offers a completely improved approach for treatment of gingivitis.
aloe vera toothpaste was certified as an antibacterial .This innovative toothgel is made using stabilized aloe vera gel from Forever's own plantations and can help you fight plaque as part of a regular brushing routine.
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aloe vera toothpaste have antimicrobial and other multipotential effects.
Whitening toothpaste that removes and prevents new stains Fights bacteria on teeth, tongue, cheeks and gums for whole mouth healthy Mint toothpaste for long lasting fresh breath Helps prevent plaque, tartar, cavities & gingivitis
Other Names:
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ACTIVE_COMPARATOR: colegate total toothpaste group
Active Ingredient: Stannous fluoride 0.454% (0.15% w/v fluoride ion) Purposes: Anticavity, Antigingivitis, Antisensitivity.
Inactive ingredients: Zinc phosphate, Water, Sorbitol, Hydrated silica, Glycerin, PEG-12, Tetras
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aloe vera toothpaste have antimicrobial and other multipotential effects.
Whitening toothpaste that removes and prevents new stains Fights bacteria on teeth, tongue, cheeks and gums for whole mouth healthy Mint toothpaste for long lasting fresh breath Helps prevent plaque, tartar, cavities & gingivitis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring interleukin -1 beta
Time Frame: one week
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measure interleukin -1 beta in gingival crevicular fluid by using ELISA
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one week
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early colonizer load of (S. sanguinis and S. mutant)
Time Frame: one week
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early colonizer load of (S. sanguinis and S. mutant) in saliva by using PCR
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one week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure the gingival sulcus erosion
Time Frame: one week
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measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
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one week
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measuring plaque accumulation
Time Frame: one week
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measure plaque accumulation on the teeth by measuring the plaque index using disclosing agent (erythrosine tablets).
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one week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U0005EDO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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