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

NCT01948349 | Completed DMC

• 1 other identifier: AAOF 49743
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Halitosis; Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Halitosis

  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.

  4-5 weeks

Secondary Outcomes (1)

• Oral Hygiene

  A total of 4-5 weeks

Study Arms (4)

Non-tongue scraping and twin brackets

NO INTERVENTION

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.

Tongue scraping with standard twin brackets

EXPERIMENTAL

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

No tongue scraping with self-ligating brackets

EXPERIMENTAL

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

Tongue scraping with SLB

EXPERIMENTAL

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; Other: Bracket design

Interventions

Tongue scraping OTHER

Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.

Tongue scraping with SLB; Tongue scraping with standard twin brackets

Bracket design OTHER

Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.

No tongue scraping with self-ligating brackets; Tongue scraping with SLB

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center, Division of Orthodontics

Farmington, Connecticut, 06030, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Taranpreet K Chandhoke, DMD, PhD

  Univeristy of Connecticut Health Center

  PRINCIPAL INVESTIGATOR

• Flavio Uribe, DDS, MDentSc

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (1)