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Active, Not Recruiting

NCT Number: NCT07467538

Ecofriendly Versus Nylon Tooth Brushes on Cariogram Outcomes

The goal of this clinical trial is to evaluate the effectiveness of an eco-friendly toothbrush compared to a conventional nylon-based toothbrush on cariogram parameters in children and adults. It will also assess the impact of toothbrush type on caries risk factors. The main questions it aims to answer are:

Does the use of an eco-friendly toothbrush improve cariogram parameters compared to a nylon-based toothbrush? Does toothbrush type influence overall caries risk in children and adults?

Participants will:

1. Be randomly assigned to use either an eco-friendly toothbrush or a nylon-based toothbrush 2. Use the assigned toothbrush as part of their daily oral hygiene routine for the study period 3. Attend scheduled follow-up visits for clinical examination and cariogram assessment

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Suez university

Suez, Egypt

About this study

This study is a randomized controlled clinical trial designed to compare the effects of an eco-friendly toothbrush and a conventional nylon-based toothbrush on cariogram parameters in children and adults. Eligible participants will be classified by age group and randomly allocated into two intervention groups. At baseline, all participants will undergo clinical examination and caries risk assessment using the Cariogram model. Standardized oral hygiene instructions will be provided to all participants. Participants in each group will use the assigned toothbrush exclusively throughout the study period.

Follow-up assessments will be conducted at predetermined intervals to evaluate changes in cariogram parameters. Compliance with toothbrush use will be monitored during follow-up visits.

The primary outcome is the change in cariogram parameters from baseline to the end of the study period. Secondary outcomes include differences in overall caries risk profile between the two toothbrush groups and between age categories. Data will be analyzed to compare the effects of toothbrush type on cariogram outcomes while accounting for age-related differences

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children's age group: Participants must be within the age range of 8 to 11 years.

This age group is specifically chosen due to the prevalence of mixed dentition, which presents unique challenges and considerations for oral hygiene practices and assessment, and is considered as being a high caries risk profile according to the cariogram parameters. (Tavargeri & Banerjee, 2021)(Lodha, Saraf, & Jawdekar, 2023) Adults' age Group: Participants must be within the age range of 18 to 35 years consider as being a high caries risk profile according to the cariogram parameters.

(AlDhawi et al., 2020; Fageeh et al., 2024) and (Fouad et al., 2022)

Exclusion criteria

  • For the children's age group:
  • Lack of parental/guardian consent for participation.
  • Currently undergoing orthodontic treatment (fixed or removable appliances).
  • Children with special healthcare needs or those who are physically unwell at the time of the study.
  • Receipt of professional dental prophylaxis within the previous 3 months.(Tavargeri & Banerjee, 2021)
  • Patient with a cariogenic diet.(Fouad et al., 2022)
  • For the adult group:
  • Currently undergoing orthodontic treatment (fixed or removable appliances).
  • Individuals with physical disabilities or any systemic health conditions (e.g.,
  • diabetes) that could influence oral health or the ability to perform oral hygiene effectively.
  • Receipt of professional dental prophylaxis (e.g., scaling and polishing) within the previous 3 months.(Fageeh et al., 2024)
  • Patients with a cariogenic diet. (Fouad et al., 2022)

Treatment and study plan

Nylon based tooth brush

Other

nylon based tooth brush will be used by children and adults age groups

Ecofriendly toothbrush

Other

Children and adults group will use ecofriendly tooth brush

Primary outcomes

  1. Caries risk profile determined by cariogram

    Time frame: 6 months follow up

    it determines if the patient is high, moderate and low caries risk after the study

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Eco-Friendly Toothbrush Compared to Nylon-Based Toothbrush on Cariogram Parameters in Children and Adults: Randomized Controlled Trial

Acronym: Ecofriendly

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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