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

Not Applicable

Completed

• Conditions: Stain Removal Efficacy
• Interventions: Drug: sodium bicarbonate powders with grain size 40 µm; Drug: sodium bicarbonate powders with grain size 65 µm

• Registration Number: NCT03140436
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2017-04-26
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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Exclusion Criteria

1. Pregnancy or current breastfeeding mother.
2. Allergy to sodium bicarbonate or the aroma of the powder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium bicarbonate powders (40 µm)	sodium bicarbonate powders with grain size 40 µm	sodium bicarbonate powders with grain size 40 µm
sodium bicarbonate powders (65 µm)	sodium bicarbonate powders with grain size 65 µm	sodium bicarbonate powders with grain size 65 µm

Primary Outcome Measures

Name	Time	Method
The time required for complete removal of extrinsic stains	2 hr	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

Secondary Outcome Measures

Name	Time	Method
Patient acceptance	2 hr	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
Operator opinion	2 hr	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

Trial Locations

Locations (1)

Kanyawat Rattanasuwan; 🇹🇭 Bangkok, Thailand