The Effect of Toothpaste Containing Aloe Vera on Gingivitis

December 5, 2020 updated by: Zainab J Abbas

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

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, one group received Aloe Vera toothpaste twice times daily and the second group received Colgate toothpaste twice daily. The first visit included PLI measurement after that Investigator removed the supra gingival plaque by cotton roll to avoid contamination with the PERIOPAPER strip during GCF collection, then GCF collected from targeted sites(upper incisors, labial side)and Unstimulated saliva collected (for early colonizer bacterial load S. sanguinis and S. mutant) after that the other clinical periodontal parameters ( BOP) were measured and then scaling was done after sample collection because of gingival bleeding which occur during scaling then inform the patient to use the coded toothpaste which gave to the participant by the assistant not involve in the study so the researcher did not know the type of toothpaste that was given to the participant (Colgate or aloe vera twice daily).The toothpastes was given for one week .The codded toothpaste was gave randomly by a decision on that day for example on Sunday Investigator gave all the participants code 1 and on other days Investigator gave to other participants code 2 .In the second visit the PLI was measured first , then the samples were collected from the same teeth after that the other periodontal parameters were collected again ( BOP). After that, participants entered a 6-day wash out period and they were asked to resume oral hygiene measures. After the washout period, the same protocol was repeated for other type of toothpaste.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Iraq
      • Baghdad, Iraq, 10001
        • Baghdad university college of dentistry

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1) 20_30 years old subject. (2) good general health. (3) presence of more than 20 teeth

-

Exclusion Criteria:

  1. active cavity caries and/or periodontal disease.
  2. ongoing orthodontic treatment.
  3. a history of antibiotics within the past 4 months.
  4. require prophylactic antibiotic coverage.
  5. require systemic and/or topical non-steroidal anti-inflammatory drugs for the past 4 months.
  6. pregnant or intended to and lactating mother.
  7. have heart valve replacement and\or any systemic 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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: aloe vera toothpaste
aloe vera toothpaste have antimicrobial and other multipotential effects.
Drug: Colgate Total
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:
  • colgate SF
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
Drug: aloe vera toothpaste
aloe vera toothpaste have antimicrobial and other multipotential effects.
Drug: Colgate Total
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:
  • colgate SF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measuring interleukin -1 beta
Time Frame: one week
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
one week
early colonizer load of (S. sanguinis and S. mutant)
Time Frame: one week
early colonizer load of (S. sanguinis and S. mutant) in saliva by using PCR
one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
measure the gingival sulcus erosion
Time Frame: one week
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
one week
measuring plaque accumulation
Time Frame: one week
measure plaque accumulation on the teeth by measuring the plaque index using disclosing agent (erythrosine tablets).
one week

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zainab J Abbas

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U0005EDO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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