Effect of Herbal Toothpaste Versus Conventional One on Black Stains in a Group of Egyptian Children: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Parental satisfaction using Likert scale regarding both interventions of management of black stains (Each response was scored as follows: (5) strongly agree, (4) agree, (3) neutral, (2) disagree and (1) strongly disagree).
Study Overview
Brief Summary
Twenty eight children with black stains on their teeth were divided into 2 groups of toothpaste to assess their effect on parental satisfaction, recurrence rate of black stains and change in number of bacteria before and after treatment
Detailed Description
TChildren will be enrolled in the study from the outpatient dental Clinic, Medical Centre of Excellence, National Research Centre, Egypt. After professional polishing of blacks stains subjects will be randomly assigned in two groups of equal number (n=28; subdivided to 14 in each group).
The test group will use herbal toothpaste (Dabur Red); (Garik powder (Red ochre), Pippali (Piper longum), Maricha (Piper nigrum), Sunthi (Zingiberofficinale), Tomarbeej (Zanthoxylumarmatum), Karpoor (Cinnamomumcamphora), Laungka Tail (Oil of Syzygiumaromaticum) and Pudinasatva (Menthapiperita).); the control group will use toothpaste with sodiumfluoride toothpaste (Signal). (Aqua, Hydrogenated Starch Hydrolysate, Hydrated Silica, PEG-32, Zinc Citrate, Sodium Lauryl Sulfate, Aroma, MenthaPiperita Oil, Rosmarinus Officinalis Leaf Oil, Cellulose Gum, Sodium Fluoride, Sodium Saccharin, Glycerin, Sodium Bicarbonate, Limonene, CI 74260).
Both test and control groups will use the assigned toothpaste twice a day for 2 months. The study will be double-blinded; sequentially numbered, opaque, sealed envelopes containing the test or the control tooth paste will be prepared.
At the beginning of the study, all subjects will complete a questionnaire including questions regarding socio-demographic variables such as age and sex. Subjects with BS(test and control groups) will also asked about oral hygiene habits such as type of dental brush (manual or electric), dietary habits such as iron supplementation and type of drinking water consumed (tap or mineral water).
The test and control subjects will receive training for home dental hygiene at enrollment and will be contacted by phone every 2 weeks for 2 months to ensure adherence to the protocol and record any recurrence of black stains.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Triple (Participant, Investigator, Outcomes Assessor) Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till teeth polishing. Blinding cannot be done during application of toothpaste because of clear visual differences between these toothpastes
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Herbal toothpaste
Intervention: Herbal toothpaste (Drug)
Control
Signal toothpaste
Intervention: Herbal toothpaste (Drug)
Outcomes
Primary Outcomes
Parental satisfaction using Likert scale regarding both interventions of management of black stains (Each response was scored as follows: (5) strongly agree, (4) agree, (3) neutral, (2) disagree and (1) strongly disagree).
Time Frame: After 2 months
using Likert scale regarding both interventions of management of black stains (Each response was scored as follows: (5) strongly agree, (4) agree, (3) neutral, (2) disagree and (1) strongly disagree).
Secondary Outcomes
- Recurrence of black stains(After 2 months)
Investigators
Mohamed Farouk Rashed
Researcher of Pediatric Dentistry, Orthodontics and Pediatric Dentistry Department, Oral and Dental Research Institute National Research Centre
National Research Centre, Egypt
