NCT04853745

Brief Summary

The use of air-polishing device that operates by directing a fine slurry of pressurized air, water, and abrasive particles has become widespread in dentistry for polishing. The introduction of abrasive powders with different properties creates the need to evaluate the effects of these powders on dental hard tissues. This study was focused on the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 11, 2021

Last Update Submit

April 18, 2021

Conditions

Keywords

glycineerythritolsodium bicarbonatex-ray microtomographygingival recessionair abrasion

Outcome Measures

Primary Outcomes (4)

  • Defect depth

    The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect depth was estimated.

    5 second

  • Demineralization depth

    The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the demineralization depth was estimated.

    5 second

  • Mineral density

    The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5 mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the mineral density was estimated.

    10 second

  • Defect volume

    The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect volume was estimated.

    5 second

Study Arms (3)

sodium bicarbonate group

Sodium bicarbonate-based powder (CLASSIC®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application.

Device: AIR-FLOW® Master Piezon

glycine group

Glycine-based powder (PERIO®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application.

Device: AIR-FLOW® Master Piezon

erythritol group

Erythritol-based powder (PLUS®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application.

Device: AIR-FLOW® Master Piezon

Interventions

AIR-FLOW® Master Piezon is intended for use in the cleaning and polishing of teeth by the projection of water,air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. This air polishing device was used for all powder instrumentations.

erythritol groupglycine groupsodium bicarbonate group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.

You may qualify if:

  • Being older than age of 18,
  • Willing to participate the study,
  • To have a single rooted tooth with gingival recession on all surfaces and need to be extracted,
  • The tooth has to be free of caries, defects and restorations.

You may not qualify if:

  • Have history of infectious diseases like Hepatitis and/or HIV (+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Dentistry

Kocaeli, Turkey (Türkiye)

Location

Related Publications (19)

  • Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.

    PMID: 21134232BACKGROUND
  • Graumann SJ, Sensat ML, Stoltenberg JL. Air polishing: a review of current literature. J Dent Hyg. 2013 Aug;87(4):173-80.

    PMID: 23986410BACKGROUND
  • Gutmann ME. Air polishing: a comprehensive review of the literature. J Dent Hyg. 1998 Summer;72(3):47-56.

    PMID: 9693568BACKGROUND
  • Weaks LM, Lescher NB, Barnes CM, Holroyd SV. Clinical evaluation of the Prophy-Jet as an instrument for routine removal of tooth stain and plaque. J Periodontol. 1984 Aug;55(8):486-8. doi: 10.1902/jop.1984.55.8.486.

    PMID: 6592321BACKGROUND
  • Berkstein S, Reiff RL, McKinney JF, Killoy WJ. Supragingival root surface removal during maintenance procedures utilizing an air-powder abrasive system or hand scaling. An in vitro study. J Periodontol. 1987 May;58(5):327-30. doi: 10.1902/jop.1987.58.5.327.

    PMID: 3295185BACKGROUND
  • Barnes CM, Russell CM, Gerbo LR, Wells BR, Barnes DW. Effects of an air-powder polishing system on orthodontically bracketed and banded teeth. Am J Orthod Dentofacial Orthop. 1990 Jan;97(1):74-81. doi: 10.1016/S0889-5406(05)81712-3. No abstract available.

    PMID: 2136972BACKGROUND
  • Kontturi-Narhi V, Markkanen S, Markkanen H. Effects of airpolishing on dental plaque removal and hard tissues as evaluated by scanning electron microscopy. J Periodontol. 1990 Jun;61(6):334-8. doi: 10.1902/jop.1990.61.6.334.

    PMID: 2366141BACKGROUND
  • Atkinson DR, Cobb CM, Killoy WJ. The effect of an air-powder abrasive system on in vitro root surfaces. J Periodontol. 1984 Jan;55(1):13-8. doi: 10.1902/jop.1984.55.1.13.

    PMID: 6319658BACKGROUND
  • Barnes CM, Covey D, Watanabe H, Simetich B, Schulte JR, Chen H. An in vitro comparison of the effects of various air polishing powders on enamel and selected esthetic restorative materials. J Clin Dent. 2014;25(4):76-87.

    PMID: 26054183BACKGROUND
  • Pelka M, Trautmann S, Petschelt A, Lohbauer U. Influence of air-polishing devices and abrasives on root dentin-an in vitro confocal laser scanning microscope study. Quintessence Int. 2010 Jul-Aug;41(7):e141-8.

    PMID: 20614037BACKGROUND
  • Sahrmann P, Ronay V, Schmidlin PR, Attin T, Paque F. Three-dimensional defect evaluation of air polishing on extracted human roots. J Periodontol. 2014 Aug;85(8):1107-14. doi: 10.1902/jop.2014.130629. Epub 2014 Jan 30.

    PMID: 24476548BACKGROUND
  • Tada K, Kakuta K, Ogura H, Sato S. Effect of particle diameter on air polishing of dentin surfaces. Odontology. 2010 Feb;98(1):31-6. doi: 10.1007/s10266-009-0113-8. Epub 2010 Feb 16.

    PMID: 20155505BACKGROUND
  • Tada K, Wiroj S, Inatomi M, Sato S. The characterization of dentin defects produced by air polishing. Odontology. 2012 Jan;100(1):41-6. doi: 10.1007/s10266-011-0019-0. Epub 2011 May 10.

    PMID: 21556726BACKGROUND
  • Herr ML, DeLong R, Li Y, Lunos SA, Stoltenberg JL. Use of a continual sweep motion to compare air polishing devices, powders and exposure time on unexposed root cementum. Odontology. 2017 Jul;105(3):311-319. doi: 10.1007/s10266-016-0282-1. Epub 2017 Jan 9.

    PMID: 28070701BACKGROUND
  • Camboni S, Donnet M. Tooth Surface Comparison after Air Polishing and Rubber Cup: A Scanning Electron Microscopy Study. J Clin Dent. 2016 Mar;27(1):13-18.

    PMID: 28390211BACKGROUND
  • Petersilka GJ, Bell M, Mehl A, Hickel R, Flemmig TF. Root defects following air polishing. J Clin Periodontol. 2003 Feb;30(2):165-70. doi: 10.1034/j.1600-051x.2003.300204.x.

    PMID: 12622860BACKGROUND
  • Petersilka GJ, Bell M, Haberlein I, Mehl A, Hickel R, Flemmig TF. In vitro evaluation of novel low abrasive air polishing powders. J Clin Periodontol. 2003 Jan;30(1):9-13. doi: 10.1034/j.1600-051x.2003.300102.x.

    PMID: 12702105BACKGROUND
  • Agger MS, Horsted-Bindslev P, Hovgaard O. Abrasiveness of an air-powder polishing system on root surfaces in vitro. Quintessence Int. 2001 May;32(5):407-11.

    PMID: 11444076BACKGROUND
  • Galloway SE, Pashley DH. Rate of removal of root structure by the use of the Prophy-Jet device. J Periodontol. 1987 Jul;58(7):464-9. doi: 10.1902/jop.1987.58.7.464.

    PMID: 3476717BACKGROUND

MeSH Terms

Conditions

Dental PlaqueGingival Recession

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesMouth DiseasesPeriodontal Atrophy

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 21, 2021

Study Start

July 24, 2019

Primary Completion

July 27, 2020

Study Completion

September 14, 2020

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations