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

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.

Study Overview

• Status: Completed
• Conditions: Stain Removal Efficacy
• Intervention / Treatment: Drug: sodium bicarbonate powders with grain size 65 µm; Drug: sodium bicarbonate powders with grain size 40 µm

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Kanyawat Rattanasuwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: sodium bicarbonate powders (65 µm); sodium bicarbonate powders with grain size 65 µm	Drug: sodium bicarbonate powders with grain size 65 µm; sodium bicarbonate powders with grain size 65 µm; Other Names: sodium bicarbonate powders
EXPERIMENTAL: sodium bicarbonate powders (40 µm); sodium bicarbonate powders with grain size 40 µm	Drug: sodium bicarbonate powders with grain size 40 µm; sodium bicarbonate powders with grain size 40 µm; Other Names: sodium bicarbonate powders

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: stain removal efficacy, air polishing powder
• Other Study ID Numbers: 2015/DT035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No