Overview

This trial has been completed.

Conditions halitosis, oral hygiene
Treatments tongue scraping, bracket design
Sponsor UConn Health
Start date October 2012
End date August 2016
Trial size 40 participants
Trial identifier NCT01948349, AAOF 49743

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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.
(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.
tongue scraping
Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.
(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.
bracket design
Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.
(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.
tongue scraping
Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.
bracket design
Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.

Primary Outcomes

Measure
Halitosis
time frame: 4-5 weeks

Secondary Outcomes

Measure
Oral Hygiene
time frame: A total of 4-5 weeks

Eligibility Criteria

Male or female participants from 11 years up to 16 years old.

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)

Additional Information

Official title Impact of Bracket Design and Oral Hygiene Maintenance on Halitosis in the Orthodontic Patient
Principal investigator Taranpreet K Chandhoke, DMD, PhD
Description Background Halitosis refers to the condition of malodor of the oral cavity (2009). Halitosis is estimated to affect 50% of the population with varying degrees of intensity and etiology (Meskin 1996). In 80% of all cases halitosis is secondary to underlying oral conditions (Miyazaki, Sakao et al. 1995).The etiology of halitosis is often caused by food debris and biofilm buildup on the teeth and tongue, deep periodontal pockets, severe carious lesions and poor dental restorations (Yaegaki and Sanada 1992; Morita and Wang 2001; Morita and Wang 2001). The odor emanating from the oral cavity is produced by microbial putrefaction of residual oral debris, resulting in production of malodorous Volatile Sulfur Compounds (VSCs) (Porter and Scully 2006). Previous studies have shown that the amount of VSCs in breath increases with the number, depth, and bleeding tendency of the periodontal pockets (Quirynen, Zhao et al. 2002). Therefore plaque control, which directly impacts periodontal health, is an important factor in the control of halitosis. Halitosis can be diagnosed by 3 primary methods (Yaegaki and Coil 2000; van den Broek, Feenstra et al. 2007) 1. Organoleptic method: The primary reference standard for the detection of oral malodor is the human nose and this method involves direct sniffing of the expired air by a trained judge. This assessment can also be done by scraping the posterior dorsum of the tongue with a spoon and smelling the contents. 2. Gas chromatography: This is the method of choice for researchers. It allows for the identification and quantification of individual components within the air sample. The measurement of VSC can be obtained and differentiated with using samples from saliva, tongue coating and breath. Disadvantages to this method are high cost and the requirement of highly trained personnel. This assessment cannot be done chairside and requires a separate laboratory procedure. 3. Sulfide monitoring: This method is superior to gas chromatography in that it is possible to measure total VSC instead of determining individual compounds. An electrochemical reaction occurs with the sulfur compounds found in the expired air, which is collected from a tube in the patient's mouth. The halimeter (Interscan Corporation, Chatsworth CA) is the most recognized device for sulfide monitoring. Management of halitosis is approached through three primary methods: masking products, mechanical reduction of micro-organisms and their substances and chemical reduction of microorganisms (van den Broek, Feenstra et al. 2008). Masking products like mint and flavored chewing gum has only a short masking effect, lasting less than 3 hours (Reingewirtz, Girault et al. 1999). Clinical studies examining the mechanical reduction of microorganisms revealed that brushing the teeth exclusively was not effective in reducing oral malodor (Yaegaki and Sanada 1992; Kleinberg and Codipilly 2002). With approximately 60% of VSCs originating on the surface of the tongue, brushing the dorsum of the tongue was found to be more effective than tooth brushing alone (Yaegaki, Coil et al. 2002). Furthermore, cleansing the tongue with a tongue scraper showed superior performance when compared to use of a toothbrush (Pedrazzi, Sato et al. 2004). Based on previous studies, the dorsum of the tongue has been shown to be an important source of oral malodor (Loesche and Kazor 2002). Chemical approaches to minimize halitosis include mouth rinses that specifically reduce the total number of microorganisms in the oral cavity. Chlorhexidine mouth rinse is the most effective anti-plaque agent on the market today and has been shown to reduce VSCs by 43% (Rosenberg, Kulkarni et al. 1991; Addy and Moran 1997). The effect of orthodontic treatment on periodontal health has been investigated in a number of studies (Zachrisson and Zachrisson 1972; Zachrisson and Alnaes 1974; Atack, Sandy et al. 1996). Inflammation of gingival tissues is observed during orthodontic treatment mainly because fixed appliances impede adequate oral hygiene measures resulting in an increase in bacterial plaque accumulation (Ristic, Vlahovic Svabic et al. 2007; Liu, Sun et al. 2011). Halitosis has been reported to reach critical levels during fixed orthodontic treatment (Babacan, Sokucu et al. 2011). Self-ligating brackets do not require an elastic or wire ligature, but have an inbuilt mechanism that can be opened and closed to secure the orthodontic archwire. In the majority of designs, this mechanism is a metal face to the bracket slot that is opened and closed with an instrument (Wenger, Deacon et al. 2008). Conventional brackets typically have multiple wings and the wire is ligated to the bracket using an elastomeric ring or stainless steel ties. The effect of self-ligating brackets on oral hygiene has yet to be fully elucidated. Self-ligating brackets have been reported to accumulate less plaque during orthodontic treatment when compared to traditional, twin brackets (Pellegrini, Sauerwein et al. 2009). This may be attributed to retentive area created by the elastomeric rings that favor the accumulation of microorganisms and food debris. However, other studies have shown that there is no difference in plaque accumulation between the two bracket types (Pandis, Vlachopoulos et al. 2008; Garcez, Suzuki et al. 2011). Objectives 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. Aims The following three aims will be performed to compare the three different appliance systems: Aim 1: Compare the impact of self-ligating and conventional brackets on oral hygiene, specifically plaque accumulation. Aim 2: Determine if an oral hygiene regimen including tongue scraping has an impact on halitosis in patients undergoing orthodontic treatment. Aim 3: Determine self-ligating brackets have an impact on minimizing halitosis during orthodontic treatment. Hypotheses Hypothesis 1: Self-ligating brackets will harbor less plaque than normal brackets. Hypothesis 2: Tongue scraping will significantly decrease halitosis in patients undergoing orthodontic treatment. Hypothesis 3: Patients with self-ligating brackets will exhibit less halitosis as measured by halimeter. Screening Procedures and Recruitment Each new patient that comes to the orthodontic clinic at the University of Connecticut Health center is assigned to a resident or a faculty. So the treating doctor will screen the new patient to see whether they need orthodontic treatment or not. If the patient requires orthodontic treatment, the patient has an additional appointment for collecting orthodontic records to develop the treatment plan. Once the treatment plan is formulated, the patient returns to discuss the treatment options and to begin the placement of orthodontic appliances. At this point the patient is ready for appliance placement and the study coordinator will screen orthodontic patient for possible inclusion in the study by checking the inclusion criteria discussed later. If the patients were suitable for inclusion, the study will be described in detail to them, and written information will be given to them. Statistical Methods The purpose of this pilot study is to determine the number of patients needed for the complete study in order to determine statistical significance. Since no previous studies exist measuring this combination of variables, we need this pilot study to determine the final sample size for this project and plan to submit a modification of this protocol to the IRB if we deem it necessary to recruit additional patients.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UConn Health.