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

NCT04407910 | Completed Phase 4 DMC

• 1 other identifier: 1-6-18-78/78
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration; Color Changes During Tooth Formation

Keywords

Tooth Bleaching; Prophylaxis; Dental Materials

Outcome Measures

Primary Outcomes (1)

• ΔE

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

  1 week

Study Arms (2)

Air-powder polishing device

EXPERIMENTAL

Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost.; Combination Product: rubber-cup+Opalescence Xtra Boost.

Rubber-cup+paste

EXPERIMENTAL

Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost.; Combination Product: rubber-cup+Opalescence Xtra Boost.

Interventions

AIRFLOW® Master device +Opalescence Xtra Boost. COMBINATION_PRODUCT

Prophylaxis techniques for pre-bleaching treatment

Air-powder polishing device; Rubber-cup+paste

rubber-cup+Opalescence Xtra Boost. COMBINATION_PRODUCT

Prophylaxis techniques for pre-bleaching treatment

Air-powder polishing device; Rubber-cup+paste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Zeliha Gonca Bek Kürklü

Adana, Sarıcam, 01120, Turkey (Türkiye)

Location

Related Publications (19)

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  PMID: 16569473 BACKGROUND

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  PMID: 1613185 BACKGROUND

• 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.

  PMID: 26759798 BACKGROUND

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  PMID: 26372629 BACKGROUND

• 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.

  PMID: 26392683 BACKGROUND

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  PMID: 20166405 BACKGROUND

• 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.

  PMID: 29568167 BACKGROUND

• Wiegand A, Drebenstedt S, Roos M, Magalhaes 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.

  PMID: 18369668 BACKGROUND

• 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. doi: 10.14219/jada.archive.2010.0081.

  PMID: 21037194 BACKGROUND

• 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.

  PMID: 28829933 BACKGROUND

• 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. doi: 10.1046/j.1365-2842.2001.00762.x.

  PMID: 11722726 BACKGROUND

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  PMID: 10492544 BACKGROUND

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  PMID: 19543926 BACKGROUND

• Kurklu ZGB, Ozcan M. Effects of preoperative air-powder polishing and rubber-cup prophylaxis on tooth bleaching: randomized controlled split-mouth clinical study. Clin Oral Investig. 2021 Oct;25(10):6007-6014. doi: 10.1007/s00784-021-04023-2. Epub 2021 Jun 18.

  PMID: 34145478 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 29, 2020
• Study Start: September 10, 2018
• Primary Completion: March 18, 2019
• Study Completion: May 17, 2019
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

TU (1)