Ecofriendly Versus Nylon Tooth Brushes on Cariogram Outcomes (Ecofriendly)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Oral Health; Caries Assessment; Caries Risk
• Intervention / Treatment: Other: Nylon based tooth brush; Other: Ecofriendly toothbrush

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Suez, Egypt
    • Faculty of Dentistry, Suez university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children age group; children will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used	Other: Nylon based tooth brush; nylon based tooth brush will be used by children and adults age groups; Other: Ecofriendly toothbrush; Children and adults group will use ecofriendly tooth brush
Experimental: Adults age group; Adults will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used	Other: Nylon based tooth brush; nylon based tooth brush will be used by children and adults age groups; Other: Ecofriendly toothbrush; Children and adults group will use ecofriendly tooth brush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries risk profile determined by cariogram	it determines if the patient is high, moderate and low caries risk after the study	6 months follow up

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Raneen Ahmed Gohar, Lecturer, Lecturer at Department of Operative Dentistry, Faculty of Dentistry, Suez University, P.O. Box:43221, Suez, Egypt

Publications and helpful links

General Publications

• Fouad, H., Elzoghbi, A., Mosallam, R., & Abouauf, E. (2022). Effectiveness of different preventive regimens on Cariogram parameters of high caries risk patients: A randomized controlled trial. Journal of International Oral Health, 14(2), 128. doi:10.4103/jioh.jioh_316_21

Helpful Links

• the ecofriendly toothbrush

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): April 18, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cariogram; ecofriendly tooth brush; nylon tooth brush; children age group; adult age group
• Other Study ID Numbers: SUEZMed- IRB-94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared for the protection of participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No