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

NCT ID: NCT03140436

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-08-31

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.

Conditions

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Stain Removal Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was designed as a double-blind, randomized split-mouth design.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Each group received treatment through a different operator (one operator per one group). Each patient was randomized using sealed envelopes according to treatment side (right or left) using powder grain size 65 µm or 40 µm. The patients and operators were blinded from the type of the powder.

Study Groups

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sodium bicarbonate powders (65 µm)

sodium bicarbonate powders with grain size 65 µm

Group Type EXPERIMENTAL

sodium bicarbonate powders with grain size 65 µm

Intervention Type DRUG

sodium bicarbonate powders with grain size 65 µm

sodium bicarbonate powders (40 µm)

sodium bicarbonate powders with grain size 40 µm

Group Type EXPERIMENTAL

sodium bicarbonate powders with grain size 40 µm

Intervention Type DRUG

sodium bicarbonate powders with grain size 40 µm

Interventions

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sodium bicarbonate powders with grain size 65 µm

sodium bicarbonate powders with grain size 65 µm

Intervention Type DRUG

sodium bicarbonate powders with grain size 40 µm

sodium bicarbonate powders with grain size 40 µm

Intervention Type DRUG

Other Intervention Names

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sodium bicarbonate powders sodium bicarbonate powders

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kanyawat Rattanasuwan

Role: STUDY_DIRECTOR

Mahidol University

Locations

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Kanyawat Rattanasuwan

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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2015/DT035

Identifier Type: -

Identifier Source: org_study_id

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