NCT07467538

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

February 6, 2026

Last Update Submit

March 8, 2026

Conditions

Keywords

ecofriendly tooth brushcariogramnylon tooth brushchildren age groupadult age group

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Children age group

EXPERIMENTAL

children will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used

Other: Nylon based tooth brushOther: Ecofriendly toothbrush

Adults age group

EXPERIMENTAL

Adults will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used

Other: Nylon based tooth brushOther: Ecofriendly toothbrush

Interventions

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

Adults age groupChildren age group

Children and adults group will use ecofriendly tooth brush

Adults age groupChildren age group

Eligibility Criteria

Age8 Months - 35 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Suez university

Suez, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

Related Links

Study Officials

  • Raneen Ahmed Gohar, Lecturer

    Lecturer at Department of Operative Dentistry, Faculty of Dentistry, Suez University, P.O. Box:43221, Suez, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at operative department

Study Record Dates

First Submitted

February 6, 2026

First Posted

March 12, 2026

Study Start

November 18, 2025

Primary Completion

April 18, 2026

Study Completion

May 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations