Clinical trial NCT04662385: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Gingivitis
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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 .
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: measuring interleukin -1 beta
timeFrame: one week
measure: early colonizer load of (S. sanguinis and S. mutant)
timeFrame: one week
Secondary outcomes:
measure: measuring plaque accumulation
timeFrame: one week
measure: measure the gingival sulcus erosion
timeFrame: one week
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad university college of dentistry
Study officials:
References: