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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04407910
Other study ID # 1-6-18-78/78
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 10, 2018
Est. completion date May 17, 2019

Study information

Verified date May 2020
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 17, 2019
Est. primary completion date March 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
AIRFLOW® Master device +Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment
rubber-cup+Opalescence Xtra Boost.
Prophylaxis techniques for pre-bleaching treatment

Locations

Country Name City State
Turkey Zeliha Gonca Bek Kürklü Adana Saricam

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

Barry TN, Bailey CW, Ashcraft-Olmscheid D, Vandewalle KS. Effect of a New Bleaching Gel on Tooth Whitening. Oper Dent. 2017 Sep/Oct;42(5):559-566. doi: 10.2341/16-200-L. — View Citation

Bernardon JK, Ferrari P, Baratieri LN, Rauber GB. Comparison of treatment time versus patient satisfaction in at-home and in-office tooth bleaching therapy. J Prosthet Dent. 2015 Dec;114(6):826-30. doi: 10.1016/j.prosdent.2015.05.014. Epub 2015 Sep 12. — View Citation

Bernardon JK, Sartori N, Ballarin A, Perdigão J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR. — View Citation

Chowdhary Z, Mohan R. Efficiency of three different polishing methods on enamel and cementum: A scanning electron microscope study. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):18-24. doi: 10.4103/jisp.jisp_40_17. — View Citation

Gallagher A, Maggio B, Bowman J, Borden L, Mason S, Felix H. Clinical study to compare two in-office (chairside) whitening systems. J Clin Dent. 2002;13(6):219-24. — View Citation

Giachetti L, Bertini F, Bambi C, Nieri M, Scaminaci Russo D. A randomized clinical trial comparing at-home and in-office tooth whitening techniques: A nine-month follow-up. J Am Dent Assoc. 2010 Nov;141(11):1357-64. — View Citation

Goldberg M, Grootveld M, Lynch E. Undesirable and adverse effects of tooth-whitening products: a review. Clin Oral Investig. 2010 Feb;14(1):1-10. doi: 10.1007/s00784-009-0302-4. Epub 2009 Jun 20. Review. — View Citation

Joiner A. The bleaching of teeth: a review of the literature. J Dent. 2006 Aug;34(7):412-9. Epub 2006 Mar 29. Review. — View Citation

Kihn PW. Vital tooth whitening. Dent Clin North Am. 2007 Apr;51(2):319-31, viii. Review. — View Citation

Muzzin KB, King TB, Berry CW. Assessing the clinical effectiveness of an aerosol reduction device for the air polisher. J Am Dent Assoc. 1999 Sep;130(9):1354-9. — View Citation

Nakamura T, Saito O, Ko T, Maruyama T. The effects of polishing and bleaching on the colour of discoloured teeth in vivo. J Oral Rehabil. 2001 Nov;28(11):1080-4. — View Citation

Patil SS, Rakhewar PS, Limaye PS, Chaudhari NP. A comparative evaluation of plaque-removing efficacy of air polishing and rubber-cup, bristle brush with paste polishing on oral hygiene status: A clinical study. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):457-62. doi: 10.4103/2231-0762.167723. — View Citation

Petersilka GJ, Ehmke B, Flemmig TF. Antimicrobial effects of mechanical debridement. Periodontol 2000. 2002;28:56-71. Review. — View Citation

Sawai MA, Bhardwaj A, Jafri Z, Sultan N, Daing A. Tooth polishing: The current status. J Indian Soc Periodontol. 2015 Jul-Aug;19(4):375-80. doi: 10.4103/0972-124X.154170. Review. — View Citation

Seghi RR, Denry I. Effects of external bleaching on indentation and abrasion characteristics of human enamel in vitro. J Dent Res. 1992 Jun;71(6):1340-4. — View Citation

Sulieman M. An overview of tooth discoloration: extrinsic, intrinsic and internalized stains. Dent Update. 2005 Oct;32(8):463-4, 466-8, 471. — View Citation

Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. Review. — View Citation

Wiegand A, Drebenstedt S, Roos M, Magalhães AC, Attin T. 12-month color stability of enamel, dentine, and enamel-dentine samples after bleaching. Clin Oral Investig. 2008 Dec;12(4):303-10. doi: 10.1007/s00784-008-0195-7. Epub 2008 Mar 28. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary ?E Delta E is a metric for understanding how the human eye perceives color difference 1 week
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