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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Orthodontic Pathological Resorption of External Root
Complication of Personal Oral Hygiene
Intervention Device: Appliance
Enrollment 68
Recruitment Details Recruitment period: December 2011 - March 2014. Location: Orthodontic Clinic, School of Dental Medicine, University of Connecticut Health, Farmington , CT
Pre-assignment Details  
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Period Title: Overall Study
Started 24 22 22
Completed 21 16 19
Not Completed 3 6 3
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance Total
Hide Arm/Group Description

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Total of all reporting groups
Overall Number of Baseline Participants 21 16 19 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 16 participants 19 participants 56 participants
16.9  (4.3) 14.8  (4.3) 14.5  (4) 15.6  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 16 participants 19 participants 56 participants
Female
7
  33.3%
10
  62.5%
9
  47.4%
26
  46.4%
Male
14
  66.7%
6
  37.5%
10
  52.6%
30
  53.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 16 participants 19 participants 56 participants
21 16 19 56
1.Primary Outcome
Title Plaque Index
Hide Description

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
Time Frame T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: Plaque Index (PI)
T0 (premolar) 0.5  (0.5) 0.7  (0.5) 0.7  (0.5)
T1(premolar) 0.8  (0.5) 1.4  (0.7) 1.3  (0.7)
T2(premolar) 0.9  (0.6) 1.1  (0.6) 1.2  (0.7)
T0(incisor) 0.6  (0.7) 0.7  (0.5) 0.9  (0.9)
T1 (incisor) 1  (0.6) 1.2  (0.5) 1.5  (1.0)
T2 (incisor) 0.9  (0.5) 1.5  (0.6) 1.6  (0.8)
2.Secondary Outcome
Title Gingival Index
Hide Description

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)
Time Frame T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: Gingival Index (GI)
T0 (premolar) 0.4  (0.5) 0.1  (0.3) 0.1  (0.2)
T1 (premolar) 0.5  (0.6) 1  (0.6) 1.2  (0.8)
T2 (premolar) 0.8  (0.5) 1  (0.7) 1.1  (0.7)
T0 (incisor) 0.6  (0.7) 0.4  (0.5) 0.4  (0.6)
T1 (incisor) 0.8  (0.7) 1.2  (0.8) 1.5  (0.7)
T2 (incisor) 1.1  (0.5) 1.7  (0.7) 1.5  (0.7)
3.Secondary Outcome
Title Bleeding Index
Hide Description

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
Time Frame T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: Bleeding index (BI)
T0 (premolar) 0.5  (0.8) 0.6  (0.7) 0.6  (0.7)
T1 (premolar) 0.6  (0.8) 1.4  (1.2) 1.3  (1.0)
T2(Premolar) 0.5  (0.7) 0.7  (1.1) 0.8  (0.1)
T0 (incisor) 0.7  (0.8) 0.9  (1) 0.8  (1)
T1 (incisor) 0.5  (0.6) 1.1  (1) 1.2  (0.9)
T2 (incisor) 0.5  (0.8) 1.6  (1.2) 1.3  (1.1)
4.Secondary Outcome
Title Total Bacterial Count
Hide Description 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).
Time Frame T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: CFU/ml
T0 7.9  (13.8) 4.7  (15.8) 4.4  (7.8)
T1 6  (9.9) 32.7  (92.4) 10.9  (18.1)
T2 10.6  (14.7) 9.6  (11.2) 14.8  (15)
5.Secondary Outcome
Title S.Mutans Count
Hide Description 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)
Time Frame T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: CFU/ml
T0 0.8  (3.7) 1  (2.1) 1.1  (2.1)
T1 0.5  (2) 0.8  (2.0) 1.6  (6.5)
T2 0.2  (0.5) 0.5  (1.2) 9.9  (1.6)
6.Secondary Outcome
Title Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)
Hide Description 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).
Time Frame T0-T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
0.3  (0.4) 0.9  (0.9) 0.8  (1)
7.Secondary Outcome
Title Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm)
Hide Description Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)
Time Frame T0-T2: 18 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description:

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Overall Number of Participants Analyzed 21 16 19
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
0.17  (0.1) 0.16  (0.11) 0.21  (0.13)
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Hide Arm/Group Description

Clear Aligners, Align Technology Inc., Santa Clara, California

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Carriere Self-Ligating Bracket, Carlsbad, CA

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

Preadjusted edge wise brackets using elastomeric ties.

Appliance: Orthodontic appliance to carry out orthodontic tooth movement.

All-Cause Mortality
Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Clear Aligner Appliance Self-ligating Appliance Conventional Bracket Appliance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
There was no protocol in place to monitor the compliance of the patient with clear aligners.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Madhur Upadhyay, Director Orthodontic Clinic, Assistant Professor
Organization: University of Connecticut Health
Phone: 860-679-3729
EMail: maupadhyay@uchc.edu
Layout table for additonal information
Responsible Party: Madhur Upadhyay, UConn Health
ClinicalTrials.gov Identifier: NCT02745626     History of Changes
Other Study ID Numbers: IRB No. 12-025-2
First Submitted: April 13, 2016
First Posted: April 20, 2016
Results First Submitted: September 21, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017