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Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment (RCT)

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ClinicalTrials.gov Identifier: NCT02745626
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Align Technology, Inc.
Information provided by (Responsible Party):
Madhur Upadhyay, UConn Health

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 induced inflammatory root resorption generated by treatment.

SA-2: To evaluate the periodontal health of the patients with the different appliance systems.

SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained in the plaque of orthodontic patients.

SA-4: To ascertain whether there is an association between the microbial count and the type of appliance being used for orthodontic treatment


Condition or disease Intervention/treatment Phase
Orthodontic Pathological Resorption of External Root Complication of Personal Oral Hygiene Device: Appliance Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Root Resorption, Microbial Colonization & Gingival Health Between Clear Aligners, Self-Ligating Brackets & Conventional Brackets- A Randomized Controlled Clinical Trial
Study Start Date : December 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Clear Aligner Appliance
Clear Aligners, Align Technology Inc., Santa Clara, California
Device: Appliance
Orthodontic appliance to carry out orthodontic tooth movement.

Experimental: Self-ligating Appliance
Carriere Self-Ligating Bracket, Carlsbad, CA
Device: Appliance
Orthodontic appliance to carry out orthodontic tooth movement.

Experimental: Conventional bracket appliance
Preadjusted edge wise brackets using elastomeric ties.
Device: Appliance
Orthodontic appliance to carry out orthodontic tooth movement.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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).

  4. 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)

  5. 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).

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. physically healthy with no relevant allergies or medical problems;
  2. above 12 years of age at commencement of treatment;
  3. in permanent dentition;
  4. less than 5 mm of anterior crowding or spacing with adequate overjet and overbite;
  5. ability to maintain adequate oral hygiene
  6. in optimum dental health without immediate need for any allied dental procedure.

Exclusion Criteria:

  1. skeletal anterior-posterior discrepancies between the maxilla and mandible (ANB ≥ 5°);
  2. centric relation - centric occlusion discrepancies of greater than 3 mm;
  3. presence of active periodontal disease.

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): NCT02745626


Locations
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United States, Connecticut
Orthodontic Center at University of Connecticut Health Center
Farmington, Connecticut, United States, 06032
Sponsors and Collaborators
UConn Health
Align Technology, Inc.
Investigators
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Principal Investigator: Madhur Upadhyay, BDS,MDS,MDSc UConn Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Madhur Upadhyay, Director (Orthodontic Clinic & Fellowship Program), Assistant Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02745626     History of Changes
Other Study ID Numbers: IRB No. 12-025-2
First Posted: April 20, 2016    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Root Resorption
Tooth Resorption
Tooth Diseases
Stomatognathic Diseases