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Clinical Trials/NCT06872827
NCT06872827CompletedNot Applicable

Effect of Herbal Toothpaste Versus Conventional One on Black Stains in a Group of Egyptian Children: A Randomized Controlled Study

National Research Centre, Egypt1 site in 1 country28 target enrollmentStarted: December 15, 2024Last updated:
Conditions
Interventions
Drugs

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

Experimental

Herbal toothpaste

Intervention: Herbal toothpaste (Drug)

Control

Active Comparator

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

Sponsor
National Research Centre, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Farouk Rashed

Researcher of Pediatric Dentistry, Orthodontics and Pediatric Dentistry Department, Oral and Dental Research Institute National Research Centre

National Research Centre, Egypt

Study Sites (1)

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