Clinical Trial: Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Root Resorption, Microbial Colonization & Gingival Health Between Clear Aligners, Self-Ligating Brackets & Conventional Brackets- A Randomized Contro

Brief Summary:

Orthodontic treatment has been traditionally carried out with fixed appliances involving the use of stainless steel brackets and archwires. The challenge has been to move teeth and their roots effectively while minimizing iatrogenic damage such as root resorption and gingival inflammation. In recent years, with the development of new appliances and brackets such as self-ligating brackets and clear aligners there have been reports of improved periodontal status, less iatrogenic root damage and improved hygiene during treatment. Although these treatment modalities have been rapidly accepted in clinical practice, both clinical and basic science research data regarding their overall biological compatibility to support higher levels of evidence based dentistry (e.g, randomized clinical trials) is lacking. In other words, their advantages and disadvantages in this regard have not yet been scientifically evaluated. Such quantification will provide invaluable information for improvements in these treatment modalities.

A randomized controlled clinical trial will be conducted with strict inclusion and exclusion criteria to test the following hypothesis (H) up to 18 months into treatment:

H-1: There is no difference in the amount of root resorption caused by the three different appliances.

H-2: Gingival health is not affected by the 'type of appliance' being used to correct the malocclusion.

H-3: There is no difference in the amount of bacterial count and the type of appliance being used for orthodontic treatment.

The hypothesis will be tested with the following specific aims (SA):

SA-1: To investigate the amount of orthodontically induc

Detailed Summary:

Importance of the research Orthodontic treatment is no longer limited mainly to children and adolescents. With increasing number of patients from older age groups seeking orthodontic treatment; there has been an increasing demand for esthetic alternatives to conventional fixed stainless steel appliances. Some issues associated with conventional fixed appliances for treatment are: 1) unaesthetic appearance of brackets especially for adult patients, many of whom are unwilling to wear braces, 2) conventional systems compromise the ability of the patient to maintain good oral hygiene; 3) increase the risk of periodontal breakdown due to constant accumulation of plaque around the brackets, wires and ill-fitting bands; 4) require many follow-up visits for appliance reactivation and adjustment if the teeth do not move as desired; 5) iatrogenic root resorption, a major medico-legal concern also poses significant problems for the clinician. Increased use of self-ligating brackets and clear aligners from Invisalign (Align Technology, Inc., Santa Clara, CA) are some of the recent developments in orthodontics that have tried to address these concerns. However clinical evidence highlighting their efficacy has not been quiet forthcoming. Present knowledge is primarily based upon case reports, case series, surveys, anecdotal reports and retrospective studies. In such a scenario it is imperative to find an optimized evidence-based treatment strategy that leads to predictable outcome with complete patient satisfaction during and after treatment while minimizing the risk for root resorption and periodontal breakdown.

RESEARCH DESIGN & METHODS:

Screening procedure:The partcipants were selected from the Division of Orthodontics, Department of Craniofacial Sciences, University of Connecticut, Health Center by two investigators: 1) faculty
Sponsor: UConn Health

Current Primary Outcome: Plaque Index [ Time Frame: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment ]

A measure of the plaque levels on the desired tooth surface. The following scores were used:

0 no plaque/debris on inspection and probing

  1. thin film of plaque only visible after probing
  2. ribbon-like layer of plaque covering the sulcus & gingival crown areas but not filling interdental space
  3. thick layer of plaque already visible at inspection and filling interdental space


Original Primary Outcome: Plaque Index [ Time Frame: 18 months ]

A measure of the plaque levels on the desired tooth surface


Current Secondary Outcome:

  • Gingival Index [ Time Frame: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment ]

    An evaluation of the gingival architecture . The following scores were used :

    0 Physiologic gingiva

    1. Mild inflammation (slight color change and little change in texture)
    2. Moderate inflammation (moderate glazing, redness, edema and hypertrophy, bleeding on probing)
    3. Severe inflammation (marked redness and hypertrophy, ulceration. tendency to bleed spontaneously)
  • Bleeding Index [ Time Frame: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment ]

    An evaluation of the amount of inflammation.

    The following scores were used:

    0 no bleeding

    1. singular bleeding point
    2. several bleeding points or a thin bleeding line along the marginal gingiva
    3. bleeding in the entire interdental gingival triangle immediately after probing
    4. profuse bleeding during probing, bleeding extending over the marginal gingiva eventually with development of blood drops
  • Total Bacterial Count [ Time Frame: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment ]
    To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution).
  • S.Mutans Count [ Time Frame: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment ]
    To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution)
  • Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm) [ Time Frame: T0-T2: 18 months of treatment ]
    Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2). Therefore the data values indicate the difference in the root length ( in mm).
  • Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm) [ Time Frame: T0-T2: 18 months of treatment ]
    Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)


Original Secondary Outcome:

  • Gingival Index [ Time Frame: 18 months ]
    An evaluation of the gingival architecture.
  • Bleeding Index [ Time Frame: 18 months ]
    An evaluation of the amount of inflammation
  • Total Bacterial Count, specifically Streptococcus mutans [ Time Frame: 18 months ]


Information By: UConn Health

Dates:
Date Received: April 13, 2016
Date Started: December 2011
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017