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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stain Removal Efficacy

Intervention / Treatment
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* Drug: sodium bicarbonate powders with grain size 65 µm
* Drug: sodium bicarbonate powders with grain size 40 µm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects who aged over 18 years old. Subjects who have healthy periodontal health or gingivitis. 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. Intrinsic stain is not present. Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above. Exclusion Criteria: Pregnancy or current breastfeeding mother. Allergy to sodium bicarbonate or the aroma of the powder
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was designed as a double-blind, randomized split-mouth design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium bicarbonate powders (65 µm)<br>sodium bicarbonate powders with grain size 65 µm | Drug: sodium bicarbonate powders with grain size 65 µm<br>* sodium bicarbonate powders with grain size 65 µm<br>* Other names: sodium bicarbonate powders;|
| Experimental: sodium bicarbonate powders (40 µm)<br>sodium bicarbonate powders with grain size 40 µm | Drug: sodium bicarbonate powders with grain size 40 µm<br>* sodium bicarbonate powders with grain size 40 µm<br>* Other names: sodium bicarbonate powders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stain removal efficacy, air polishing powder