The Effect of Toothpaste Containing Aloe Vera on Gingivitis

Generalized Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662385
• Other study ID #: U0005EDO
• Status: Completed
• Phase: Phase 2
• Start date: March 13, 2020
• Est. completion date: November 19, 2020

Study information

• Verified date: December 2020
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 19, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Generalized Gingivitis
• Gingivitis

Intervention

Drug:
• aloe vera toothpaste
aloe vera toothpaste have antimicrobial and other multipotential effects.
• 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

Locations

Country	Name	City	State
Iraq	Baghdad university college of dentistry	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Zainab J Abbas

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring interleukin -1 beta	measure interleukin -1 beta in gingival crevicular fluid by using ELISA	one week
Primary	early colonizer load of (S. sanguinis and S. mutant)	early colonizer load of (S. sanguinis and S. mutant) in saliva by using PCR	one week
Secondary	measuring plaque accumulation	measure plaque accumulation on the teeth by measuring the plaque index using disclosing agent (erythrosine tablets).	one week
Secondary	measure the gingival sulcus erosion	measure the gingival sulcus erosion and destruction by measuring the bleeding on probing index using periodontal probe	one week