Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders

Stain Removal Efficacy Clinical Trial

Official title:

Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140436
• Other study ID #: 2015/DT035
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: May 2, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.

Description:

Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Healthy subjects who aged over 18 years old.

2. Subjects who have healthy periodontal health or gingivitis.

3. At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right & left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.

4. Intrinsic stain is not present.

5. Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.

Exclusion Criteria:

1. Pregnancy or current breastfeeding mother.

2. Allergy to sodium bicarbonate or the aroma of the powder

Related Conditions & MeSH terms

• Stain Removal Efficacy

Intervention

Drug:
• sodium bicarbonate powders with grain size 65 µm
sodium bicarbonate powders with grain size 65 µm
• sodium bicarbonate powders with grain size 40 µm
sodium bicarbonate powders with grain size 40 µm

Locations

Country	Name	City	State
Thailand	Kanyawat Rattanasuwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time required for complete removal of extrinsic stains	Comparison of the time required for the complete removal of extrinsic stains by sodium bicarbonate powders with a grain size of 65 µm and 40 µm	2 hr
Secondary	Patient acceptance	The answers from the questionnaires about the clinical impressions of patients after treatment with sodium bicarbonate powders with a grain size of 65 µm and 40 µm	2 hr
Secondary	Operator opinion	The answers from the questionnaires about the operators' opinions after using of sodium bicarbonate powders with a grain size of 65 µm and 40 µm	2 hr