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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Connecticut Health Center
Sponsor:
Information provided by (Responsible Party):
Taranpreet Chandhoke, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01948349
First received: September 18, 2013
Last updated: March 27, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Halitosis [ Time Frame: 4-5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948349

Contacts
Contact: Taranpreet K Chandhoke, DMD, PhD 860-679-3625 chandhoke@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center, Division of Orthodontics Recruiting
Farmington, Connecticut, United States, 06030
Contact: Chandhoke    860-679-3625      
Principal Investigator: Taranpreet K Chandhoke, DMD, PhD         
Sub-Investigator: Khalid Almas, DDS, MDS         
Sub-Investigator: Flavio Uribe, DDS, MDentSc         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Taranpreet K Chandhoke, DMD, PhD Univeristy of Connecticut Health Center
  More Information

Publications:

Responsible Party: Taranpreet Chandhoke, Assistant Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01948349     History of Changes
Other Study ID Numbers: AAOF 49743
Study First Received: September 18, 2013
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014