Evaluation of Toothpaste on Dental Plaque

NCT ID: NCT05868590

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2024-12-31

Brief Summary

The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.

Detailed Description

The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Magnesium Containing Toothpaste-ROCS

The participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the test.In the first stage, the preliminary plaque in the children will record by the first researcher using plaque dye.After plaque disclosing the researcher brush children's teeth with ROCS active magnesium toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.

Group Type: EXPERIMENTAL

Toothpaste

Intervention Type: OTHER

Using two different toothpastes for removal of the dental plaque in children.

Fluoride Toothpaste-COLGATE

After 2 weeks, the same participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the retest.Initial, the preliminary plaque in the children will record by the first researcher using plaque dye. After plaque disclosing the researcher brush children's teeth with Colgate fluoride toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.

Group Type: EXPERIMENTAL

Toothpaste

Intervention Type: OTHER

Using two different toothpastes for removal of the dental plaque in children.

Interventions

Toothpaste

Using two different toothpastes for removal of the dental plaque in children.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 9-12 years
• The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
• Absence of orthodontic appliances/brackets
• No physical limitations
• No previous trauma history
• It was determined as the absence of soft-hard tissue pathology.

Exclusion Criteria

• Patients not between 9-12 years
• The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
• Presence of orthodontic appliances/brackets
• Physical limitations
• Previous trauma history
• It was determined as the presence of soft-hard tissue pathology.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Haner Direskeneli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Betul Kargul, Prof.Dr.

Role: CONTACT

bkargul@marmara.edu.tr

+905323267207

Nur Kodaman Dokumacigil, DDS

Role: CONTACT

nurkodaman92@gmail.com

+905418091710

Other Identifiers

2022/37

Identifier Type: -

Identifier Source: org_study_id