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The Effect of Toothpaste Containing Aloe Vera on Gingivitis

Primary Purpose

Generalized Gingivitis

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
aloe vera toothpaste
Colgate Total
Sponsored by
Zainab J Abbas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Generalized Gingivitis

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Baghdad university college of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aloe vera toothpaste group

colegate total toothpaste group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

measuring interleukin -1 beta
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
early colonizer load of (S. sanguinis and S. mutant)
early colonizer load of (S. sanguinis and S. mutant) in saliva by using PCR

Secondary Outcome Measures

measuring plaque accumulation
measure plaque accumulation on the teeth by measuring the plaque index using disclosing agent (erythrosine tablets).
measure the gingival sulcus erosion
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe

Full Information

First Posted
November 28, 2020
Last Updated
December 5, 2020
Sponsor
Zainab J Abbas
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1. Study Identification

Unique Protocol Identification Number
NCT04662385
Brief Title
The Effect of Toothpaste Containing Aloe Vera on Gingivitis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zainab J Abbas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Gingivitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
twenty-four adult patients with generalized gingivitis participated in the double blinded randomized controlled crossover study divided into two groups, aloe vera and colgate toothpaste used during seven days , one group received aloe vera toothpaste twice times daily and the second group received colgate toothpaste twice dialy .
Masking
ParticipantInvestigator
Masking Description
third professional person give the one of opaque coded toothpaste to the participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aloe vera toothpaste group
Arm Type
Experimental
Arm Description
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.
Arm Title
colegate total toothpaste group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
aloe vera toothpaste
Intervention Description
aloe vera toothpaste have antimicrobial and other multipotential effects.
Intervention Type
Drug
Intervention Name(s)
Colgate Total
Other Intervention Name(s)
colgate SF
Intervention Description
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
Primary Outcome Measure Information:
Title
measuring interleukin -1 beta
Description
measure interleukin -1 beta in gingival crevicular fluid by using ELISA
Time Frame
one week
Title
early colonizer load of (S. sanguinis and S. mutant)
Description
early colonizer load of (S. sanguinis and S. mutant) in saliva by using PCR
Time Frame
one week
Secondary Outcome Measure Information:
Title
measuring plaque accumulation
Description
measure plaque accumulation on the teeth by measuring the plaque index using disclosing agent (erythrosine tablets).
Time Frame
one week
Title
measure the gingival sulcus erosion
Description
measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe
Time Frame
one week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
twenty-four adult male and female patients with generalized gingivitis
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) 20_30 years old subject. (2) good general health. (3) presence of more than 20 teeth - 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.
Facility Information:
Facility Name
Baghdad university college of dentistry
City
Baghdad
ZIP/Postal Code
10001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Toothpaste Containing Aloe Vera on Gingivitis

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