Office Bleaching Treatment by Using Rubber-cup and Air-powder Polishing Device Prophylaxis in Rondomised Clinical Design

May 26, 2020 updated by: zeliha gonca bek kurklu, Cukurova University

Effects of Pre-operative Air-powder Polishing and Rubber-cup Prophylaxis on Tooth Bleaching Outcomes: Randomised Controlled Split-mouth Clinical Study

The increasing demand for whitening teeth necessitates requirements and guidelines to ensure the efficacy of products and bleaching techniques. So far there is no comparative study to evaluate the effectiveness of pre-operative air-powder polishing device (APD) and rubber-cup prophylaxis on tooth bleaching in-office. Office-bleaching has some advantages such as avoiding soft tissue irritation, preventing the use of excess material and producing immediate esthetic results.

The aim this study is to compare the effects of pre-operative air-powder polishing and rubber-cup prophylaxis on tooth bleaching outcomes. The null hypothesis of this research was that there would be no difference in the change in according to the type of prophylaxis on tooth-bleaching outcomes.△L,△a,△b,△E and △SGU.

The results of the study show that both rubber cup prophylaxis and APD devices can be equally used before bleaching treatment as there were no statistical differences in color change.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tooth color was measured using spectrophotometer VITA Easyshade V (Vita Zahnfabrik, Germany). The spectrophotometer was calibrated before use in each participant and the device tip was placed on middle thirds of the labial surface of teeth as suggested by the manufacturer's manual.

The tooth color was measured before initial prophylaxis (baseline), immediately after bleaching and after one week. The digital spectrophotometer used in the current study measures the shade of teeth based on the CIE (Commission Internationale de l'éclairage) L*a*b* color space system. This system expresses color as three values: L* for the lightness from black (0) to white (100), a* from green (-) to red (+), and b* from blue (-) to yellow (+). The following values were recorded in the units of CIE L*a*b* color space.

-Data of lightness (L*) and a* and b*axis

-△e: a teeth color change (△e*) was derived as: △e = [(△L *)2+ (△a *)2 + (△b *)2]1/2 While making Shade guide units (SGU) measurements, the bleached index is set according to the VITA Bleached guide 3D-MASTER at spectrophotometer for the measured shade. The measured bleached index after treatment was subtracted from the baseline value. The difference corresponded to the change of the SGU (△ SGU) achieved immediately and 1 week after the bleaching treatment.

The patients had bleaching treatment on the maxillary anterior area including right and left canines. The right and left sides of the patients were randomized by toss of a coin to receive polishing with rubber cup prophylaxis or air powder polishing system before bleaching.

All prophylaxis procedures were performed by same clinician (M.O.). The rubber cup prophylaxis was applied with low-speed handpieces. A rubber cup was attached to the prophy-angle. The handpiece used at a steady slow pace of 2500-3000 rpm. The rubber cup contacted each tooth surface for an average of 5 seconds together with polishing paste consisting of flour of pumice, glycerin and fluoride.

The air polishing treatment was performed by AIRFLOW® Master device (EMS, Nyon, Switzerland) with a six LED (Light Emitting Diode) power setting (2.2 bars dynamic pressure inside powder chamber) and an 11 LED (35 mL/min) water setting for 30 seconds (powder consumption was 1.1 g). Sodium bicarbonate air-powder polishing powder (AIR-FLOW® Plus, EMS Electro Medical Systems, Nyon, Switzerland) was used. The nozzle was held 3-4 mm from the tooth surface and the tip was angulated diagonally. The spray was delivered for an average of 5 seconds using a constant circular motion for each tooth. The spray was directed towards the middle one-thirds of the exposed tooth.

All bleaching procedures were performed by same clinician (Z.G.B.K.). The bleaching agent (Opalescence Xtra Boost/ Ultradent, South Jordan, Utah, USA) was prepared and used following the manufacturer's instructions. Opal Dam (Ultradent, South Jordan, Utah, USA) was used for protection of the gingiva. The bleaching gel was then applied to form 1-2 mm thickness on the buccal surfaces of the teeth of both arches. The gel remained on teeth for 15 minutes and was then suctioned from teeth using a surgical suction tip. This application was repeated a second time in the same session.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sarıcam
      • Adana, Sarıcam, Turkey, 01120
        • Zeliha Gonca Bek Kürklü

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - being at least 18 years of age
  • having minimum of 20 natural teeth (including incisors, canines, and premolars in both arches)
  • having good oral hygiene (Plaque index <1, Gingival index <1)

Exclusion Criteria:

  • having restorations or active caries on the anterior teeth of either arch
  • presence of tetracycline staining or fluorosis
  • general hypersensitivity
  • gingival recession or periodontal disease
  • smokers
  • pregnant or lactating women
  • history of prior bleaching treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air-powder polishing device
Combination product: AIRFLOW® Master device +Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment
Combination product: rubber-cup+Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment
Experimental: Rubber-cup+paste
Combination product: AIRFLOW® Master device +Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment
Combination product: rubber-cup+Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔE
Time Frame: 1 week
Delta E is a metric for understanding how the human eye perceives color difference
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

March 18, 2019

Study Completion (Actual)

May 17, 2019

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-6-18-78/78

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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