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

Primary Purpose

Tooth Discoloration, Color Changes During Tooth Formation

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
AIRFLOW® Master device +Opalescence Xtra Boost.
rubber-cup+Opalescence Xtra Boost.
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Tooth Bleaching, Prophylaxis, Dental Materials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zeliha Gonca Bek Kürklü

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Air-powder polishing device

Rubber-cup+paste

Arm Description

Outcomes

Primary Outcome Measures

ΔE
Delta E is a metric for understanding how the human eye perceives color difference

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
May 26, 2020
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04407910
Brief Title
Office Bleaching Treatment by Using Rubber-cup and Air-powder Polishing Device Prophylaxis in Rondomised Clinical Design
Official Title
Effects of Pre-operative Air-powder Polishing and Rubber-cup Prophylaxis on Tooth Bleaching Outcomes: Randomised Controlled Split-mouth Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Color Changes During Tooth Formation
Keywords
Tooth Bleaching, Prophylaxis, Dental Materials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
We have two groups applied to split-mouth experimental units. Left side of maxillary have received rubber-cup and right side of maxillary of each subject.have APD prophylaxis respectively.
Masking
Participant
Masking Description
Single blind participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air-powder polishing device
Arm Type
Experimental
Arm Title
Rubber-cup+paste
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
AIRFLOW® Master device +Opalescence Xtra Boost.
Intervention Description
Prophylaxis techniques for pre-bleaching treatment
Intervention Type
Combination Product
Intervention Name(s)
rubber-cup+Opalescence Xtra Boost.
Intervention Description
Prophylaxis techniques for pre-bleaching treatment
Primary Outcome Measure Information:
Title
ΔE
Description
Delta E is a metric for understanding how the human eye perceives color difference
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zeliha Gonca Bek Kürklü
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01120
Country
Turkey

12. IPD Sharing Statement

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Links:
URL
https://pubmed.ncbi.nlm.nih.gov/
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Office Bleaching Treatment by Using Rubber-cup and Air-powder Polishing Device Prophylaxis in Rondomised Clinical Design

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