Evaluation of Toothpaste on Dental Plaque

Sponsor

Marmara University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05868590

Collaborator

(none)

Enrollment

Arms

18.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Other: Toothpaste	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children

Anticipated Study Start Date :

May 26, 2023

Anticipated Primary Completion Date :

Jan 26, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Toothpaste Using two different toothpastes for removal of the dental plaque in children.
Experimental: 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.	Other: Toothpaste Using two different toothpastes for removal of the dental plaque in children.

Arm

Intervention/Treatment

Experimental: 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.

Other: Toothpaste

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

Experimental: 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.

Other: Toothpaste

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

Outcome Measures

Primary Outcome Measures

Active Magnesium Containing Toothpaste (ROCS) [1 month]
Active magnesium containing toothpaste can find to be effective in reducing plaque of Turesky-Modified Quinley-Hein-Plaque-Index (TMQHPI) score when compare to Fluoride toothpaste with single-use brushing in children

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haner Direskeneli, Professor, Marmara University

ClinicalTrials.gov Identifier:

NCT05868590

Other Study ID Numbers:

2022/37

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Plaque

Study Results

No Results Posted as of May 22, 2023