We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Bracket Design and Oral Hygiene Maintenance on Halitosis in the Orthodontic Patient

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01948349
First Posted: September 23, 2013
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taranpreet Chandhoke, UConn Health
  Purpose
The advantage of self-ligating brackets on periodontal health has yet to be determined. In addition, the utilization of tongue scraping as an adjunct to traditional oral hygiene measures has yet to be studied in orthodontic patients. The aim of this study is to evaluate the effect of bracket type on plaque accumulation and also the impact of the appliance on oral malodor. In addition, the effect of tongue scraping on halitosis will be studied in patients undergoing orthodontic treatment. We hypothesize that self-ligating brackets will harbor less plaque than normal brackets, that tongue scraping will significantly decrease halitosis in patients undergoing orthodontic treatment and that patients with self-ligating brackets will exhibit less halitosis as measured by halimeter.

Condition Intervention
Halitosis Oral Hygiene Other: Tongue scraping Other: Bracket design

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Bracket Design and Oral Hygiene Maintenance on Halitosis in the Orthodontic Patient

Resource links provided by NLM:


Further study details as provided by Taranpreet Chandhoke, UConn Health:

Primary Outcome Measures:
  • Halitosis [ Time Frame: 4-5 weeks ]
    Once brackets are placed (T0), a NiTi orthodontic wire will be placed and ligated into the brackets. Baseline halitosis measurements will be taken at T0. At 7-10 days (T1) and 4 to 5 weeks (T2) of full appliance placement the same measurements will be taken by the same investigator.


Secondary Outcome Measures:
  • Oral Hygiene [ Time Frame: A total of 4-5 weeks ]
    Similar to halitosis measurements, three indices of oral hygiene (gingival index, plaque index and bleeding index) will be observed at T0, T1 and T2.


Estimated Enrollment: 40
Study Start Date: October 2012
Study Completion Date: September 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non-tongue scraping and twin brackets
Patients in this subgroup will be instructed to follow standard at-home oral hygiene protocols. They will be instructed by the study coordinators to utilize the traditional Bass brushing technique [31], brushing twice daily (morning and night) for 2 minutes each time. Patients will all be given the same toothbrush and toothpaste to use during the study. They will also be instructed on the method of flossing and be shown how to use interdental brushes to clean around the orthodontic appliances.
Experimental: Tongue scraping with standard twin brackets
Patients allocated to this group will receive the same oral hygiene protocol as the non-tongue scraping subjects. However, they will also be in instructed and asked to use the tongue-scraping method of cleaning the tongue as part of their oral hygiene regimen. Patients will be instructed to scrape the tongue once during their nighttime oral hygiene session of brushing and flossing. All patients in this subgroup will be given the same tongue scraper.
Other: Tongue scraping
Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.
Experimental: No tongue scraping with self-ligating brackets
Patients in this group are treated with passive self-ligating Carrier brackets (Ortho Organizer). They will be instructed to use the traditional Bass brushing technique, brushing twice daily (morning and night) for 2 minutes each time. Patients will all be given the same toothbrush and toothpaste to use during the study. They will also be instructed on the method of flossing and be shown how to use interdental brushes to clean around the orthodontic appliances.
Other: Bracket design
Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.
Experimental: Tongue scraping with SLB
Patients in this group are treated with passive self-ligating Carrier brackets (Ortho Organizer). Patients allocated to this group will receive the same oral hygiene protocol as non-tongue scraping subjects. However, they will also be in instructed and asked to use the tongue-scraping method of cleaning the tongue as part of their oral hygiene regimen. Patients will be instructed to scrape the tongue once during their nighttime oral hygiene session of brushing and flossing. All patients in this subgroup will be given the same tongue scraper.
Other: Tongue scraping
Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.
Other: Bracket design
Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fair oral hygiene
  • Permanent dentition present with eruption of one or both premolars in each quadrant
  • No active carious lesions
  • Patients with overall good health
  • No previous orthodontic treatment

Exclusion Criteria:

  • Previous orthodontic treatment
  • Missing or unerupted permanent teeth (both premolars, canines, lateral or central incisors)
  • Extremely poor oral hygiene at baseline
  • Existence of active carious lesions (not restored)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948349


Locations
United States, Connecticut
University of Connecticut Health Center, Division of Orthodontics
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
Principal Investigator: Taranpreet K Chandhoke, DMD, PhD Univeristy of Connecticut Health Center
Principal Investigator: Flavio Uribe, DDS, MDentSc UConn Health
  More Information

Publications:
Addy M, Moran JM. Clinical indications for the use of chemical adjuncts to plaque control: chlorhexidine formulations. Periodontol 2000. 1997 Oct;15:52-4. Review.
Atack NE, Sandy JR, Addy M. Periodontal and microbiological changes associated with the placement of orthodontic appliances. A review. J Periodontol. 1996 Feb;67(2):78-85. Review.
Babacan H, Sokucu O, Marakoglu I, Ozdemir H, Nalcaci R. Effect of fixed appliances on oral malodor. Am J Orthod Dentofacial Orthop. 2011 Mar;139(3):351-5. doi: 10.1016/j.ajodo.2009.03.055.
BASS CC. An effective method of personal oral hygiene; part II. J La State Med Soc. 1954 Mar;106(3):100-12.
Bornstein MM, Kislig K, Hoti BB, Seemann R, Lussi A. Prevalence of halitosis in the population of the city of Bern, Switzerland: a study comparing self-reported and clinical data. Eur J Oral Sci. 2009 Jun;117(3):261-7. doi: 10.1111/j.1600-0722.2009.00630.x.
Garcez AS, Suzuki SS, Ribeiro MS, Mada EY, Freitas AZ, Suzuki H. Biofilm retention by 3 methods of ligation on orthodontic brackets: a microbiologic and optical coherence tomography analysis. Am J Orthod Dentofacial Orthop. 2011 Oct;140(4):e193-8. doi: 10.1016/j.ajodo.2011.04.019.
Kleinberg I, Codipilly DM. Cysteine challenge testing: a powerful tool for examining oral malodour processes and treatments in vivo. Int Dent J. 2002 Jun;52 Suppl 3:221-8.
Liu H, Sun J, Dong Y, Lu H, Zhou H, Hansen BF, Song X. Periodontal health and relative quantity of subgingival Porphyromonas gingivalis during orthodontic treatment. Angle Orthod. 2011 Jul;81(4):609-15. doi: 10.2319/082310-352.1. Epub 2011 Feb 9.
Loesche WJ, Kazor C. Microbiology and treatment of halitosis. Periodontol 2000. 2002;28:256-79. Review.
Meskin LH. A breath of fresh air. J Am Dent Assoc. 1996 Sep;127(9):1282, 1284, 1286 passim.
Miyazaki H, Sakao S, Katoh Y, Takehara T. Correlation between volatile sulphur compounds and certain oral health measurements in the general population. J Periodontol. 1995 Aug;66(8):679-84.
Morita M, Wang HL. Relationship between sulcular sulfide level and oral malodor in subjects with periodontal disease. J Periodontol. 2001 Jan;72(1):79-84.
Morita M, Wang HL. Relationship of sulcular sulfide level to severity of periodontal disease and BANA test. J Periodontol. 2001 Jan;72(1):74-8.
Pandis N, Vlachopoulos K, Polychronopoulou A, Madianos P, Eliades T. Periodontal condition of the mandibular anterior dentition in patients with conventional and self-ligating brackets. Orthod Craniofac Res. 2008 Nov;11(4):211-5. doi: 10.1111/j.1601-6343.2008.00432.x.
Pedrazzi V, Sato S, de Mattos Mda G, Lara EH, Panzeri H. Tongue-cleaning methods: a comparative clinical trial employing a toothbrush and a tongue scraper. J Periodontol. 2004 Jul;75(7):1009-12.
Pellegrini P, Sauerwein R, Finlayson T, McLeod J, Covell DA Jr, Maier T, Machida CA. Plaque retention by self-ligating vs elastomeric orthodontic brackets: quantitative comparison of oral bacteria and detection with adenosine triphosphate-driven bioluminescence. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):426.e1-9; discussion 426-7. doi: 10.1016/j.ajodo.2008.12.002.
Porter SR, Scully C. Oral malodour (halitosis). BMJ. 2006 Sep 23;333(7569):632-5. Review.
Quirynen M, Zhao H, van Steenberghe D. Review of the treatment strategies for oral malodour. Clin Oral Investig. 2002 Mar;6(1):1-10. Review.
Reingewirtz Y, Girault O, Reingewirtz N, Senger B, Tenenbaum H. Mechanical effects and volatile sulfur compound-reducing effects of chewing gums: comparison between test and base gums and a control group. Quintessence Int. 1999 May;30(5):319-23.
Ristic M, Vlahovic Svabic M, Sasic M, Zelic O. Clinical and microbiological effects of fixed orthodontic appliances on periodontal tissues in adolescents. Orthod Craniofac Res. 2007 Nov;10(4):187-95.
Rosenberg M, Kulkarni GV, Bosy A, McCulloch CA. Reproducibility and sensitivity of oral malodor measurements with a portable sulphide monitor. J Dent Res. 1991 Nov;70(11):1436-40.
Schaefer I, Braumann B. Halitosis, oral health and quality of life during treatment with Invisalign(®) and the effect of a low-dose chlorhexidine solution. J Orofac Orthop. 2010 Nov;71(6):430-41. doi: 10.1007/s00056-010-1040-6. Epub 2010 Nov 17. English, German.
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35.
van den Broek AM, Feenstra L, de Baat C. A review of the current literature on management of halitosis. Oral Dis. 2008 Jan;14(1):30-9. doi: 10.1111/j.1601-0825.2006.01350.x. Review.
Wenger NA, Deacon S, Harradine NW. A randomized control clinical trial investigating orthodontic bond failure rates when using Orthosolo universal bond enhancer compared to a conventional bonding primer. J Orthod. 2008 Mar;35(1):27-32. doi: 10.1179/146531207225022392.
Yaegaki K, Coil JM, Kamemizu T, Miyazaki H. Tongue brushing and mouth rinsing as basic treatment measures for halitosis. Int Dent J. 2002 Jun;52 Suppl 3:192-6.
Yaegaki K, Sanada K. Volatile sulfur compounds in mouth air from clinically healthy subjects and patients with periodontal disease. J Periodontal Res. 1992 Jul;27(4 Pt 1):233-8.
Yaegaki K, Sanada K. Effects of a two-phase oil-water mouthwash on halitosis. Clin Prev Dent. 1992 Jan-Feb;14(1):5-9.
Zachrisson BU, Alnaes L. Periodontal condition in orthodontically treated and untreated individuals. II. Alveolar bone loss: radiographic findings. Angle Orthod. 1974 Jan;44(1):48-55.
Zachrisson S, Zachrisson BU. Gingival condition associated with orthodontic treatment. Angle Orthod. 1972 Jan;42(1):26-34.

Responsible Party: Taranpreet Chandhoke, Assistant Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01948349     History of Changes
Other Study ID Numbers: AAOF 49743
First Submitted: September 18, 2013
First Posted: September 23, 2013
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms


To Top