The Effect of Toothpaste Containing Aloe Vera on Gingivitis

NCT04662385 | Completed Phase 2

• 1 other identifier: U0005EDO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Gingivitis

Outcome Measures

Primary Outcomes (2)

• measuring interleukin -1 beta

  measure interleukin -1 beta in gingival crevicular fluid by using ELISA

  one week

• 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 Outcomes (2)

• measuring plaque accumulation

  one week

• measure the gingival sulcus erosion

  one week

Study Arms (2)

aloe vera toothpaste group

EXPERIMENTAL

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; Drug: Colgate Total

colegate total toothpaste group

ACTIVE COMPARATOR

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; Drug: Colgate Total

Interventions

aloe vera toothpaste DRUG

aloe vera toothpaste have antimicrobial and other multipotential effects.

aloe vera toothpaste group; colegate total toothpaste group

Colgate Total DRUG

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

Also known as: colgate SF

aloe vera toothpaste group; colegate total toothpaste group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: twenty-four adult male and female patients with generalized gingivitis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zainab J Abbas: lead

Study Sites (1)

Baghdad university college of dentistry

Baghdad, 10001, Iraq

Location

MeSH Terms

Interventions

hydrated silica gel-based toothpaste

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: third professional person give the one of opaque coded toothpaste to the participant
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BCs

Model Details: 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 .

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 10, 2020
• Study Start: March 13, 2020
• Primary Completion: May 26, 2020
• Study Completion: November 19, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)