Effect of Herbal Toothpaste Versus Conventional One on Black Stains

NCT06872827 | Completed DMC

• 1 other identifier: 341
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Black Stains

Keywords

black stains; bacteria; herbal; child

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  After 2 months

Secondary Outcomes (1)

• Recurrence of black stains

  After 2 months

Other Outcomes (1)

• Change in number of bacteria before and after treatment

  After 2 months

Study Arms (2)

Intervention

EXPERIMENTAL

Herbal toothpaste

Drug: Herbal toothpaste

Control

ACTIVE COMPARATOR

Signal toothpaste

Drug: Herbal toothpaste

Interventions

Herbal toothpaste DRUG

Intervention

Also known as: Dabur Red toothpaste

Control; Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 6 to 12 years
• Free medical history.
• Presence of black stains covering at least two teeth.
• Good oral hygiene.

You may not qualify if:

• Children on iron supplements
• Presence of intrinsic stains or fluorosis
• Children using electric toothbrush.
• Children took mouthwash or antibiotic in the last month.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Dokki, Giza Governorate, 12622, Egypt

Location

Study Officials

• Mohamed F Rashed, Researcher

  National Research Centre, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Pediatric Dentistry, Orthodontics and Pediatric Dentistry Department, Oral and Dental Research Institute National Research Centre

Model Details: Randomized controlled parallel triple blinded study

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: December 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)