Trial Outcomes & Findings for Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment (NCT NCT02745626)
NCT ID: NCT02745626
Last Updated: 2017-03-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment
Results posted on
2017-03-10
Participant Flow
Recruitment period: December 2011 - March 2014. Location: Orthodontic Clinic, School of Dental Medicine, University of Connecticut Health, Farmington , CT
Participant milestones
| Measure |
Clear Aligner Appliance
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment
Baseline characteristics by cohort
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.9 years
STANDARD_DEVIATION 4.3 • n=99 Participants
|
14.8 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
14.5 years
STANDARD_DEVIATION 4 • n=206 Participants
|
15.6 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
16 participants
n=107 Participants
|
19 participants
n=206 Participants
|
56 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatmentA 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
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Plaque Index
T0 (premolar)
|
0.5 Plaque Index (PI)
Standard Deviation 0.5
|
0.7 Plaque Index (PI)
Standard Deviation 0.5
|
0.7 Plaque Index (PI)
Standard Deviation 0.5
|
|
Plaque Index
T1(premolar)
|
0.8 Plaque Index (PI)
Standard Deviation 0.5
|
1.4 Plaque Index (PI)
Standard Deviation 0.7
|
1.3 Plaque Index (PI)
Standard Deviation 0.7
|
|
Plaque Index
T2(premolar)
|
0.9 Plaque Index (PI)
Standard Deviation 0.6
|
1.1 Plaque Index (PI)
Standard Deviation 0.6
|
1.2 Plaque Index (PI)
Standard Deviation 0.7
|
|
Plaque Index
T0(incisor)
|
0.6 Plaque Index (PI)
Standard Deviation 0.7
|
0.7 Plaque Index (PI)
Standard Deviation 0.5
|
0.9 Plaque Index (PI)
Standard Deviation 0.9
|
|
Plaque Index
T1 (incisor)
|
1 Plaque Index (PI)
Standard Deviation 0.6
|
1.2 Plaque Index (PI)
Standard Deviation 0.5
|
1.5 Plaque Index (PI)
Standard Deviation 1.0
|
|
Plaque Index
T2 (incisor)
|
0.9 Plaque Index (PI)
Standard Deviation 0.5
|
1.5 Plaque Index (PI)
Standard Deviation 0.6
|
1.6 Plaque Index (PI)
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatmentAn 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)
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Gingival Index
T0 (premolar)
|
0.4 Gingival Index (GI)
Standard Deviation 0.5
|
0.1 Gingival Index (GI)
Standard Deviation 0.3
|
0.1 Gingival Index (GI)
Standard Deviation 0.2
|
|
Gingival Index
T1 (premolar)
|
0.5 Gingival Index (GI)
Standard Deviation 0.6
|
1 Gingival Index (GI)
Standard Deviation 0.6
|
1.2 Gingival Index (GI)
Standard Deviation 0.8
|
|
Gingival Index
T2 (premolar)
|
0.8 Gingival Index (GI)
Standard Deviation 0.5
|
1 Gingival Index (GI)
Standard Deviation 0.7
|
1.1 Gingival Index (GI)
Standard Deviation 0.7
|
|
Gingival Index
T0 (incisor)
|
0.6 Gingival Index (GI)
Standard Deviation 0.7
|
0.4 Gingival Index (GI)
Standard Deviation 0.5
|
0.4 Gingival Index (GI)
Standard Deviation 0.6
|
|
Gingival Index
T1 (incisor)
|
0.8 Gingival Index (GI)
Standard Deviation 0.7
|
1.2 Gingival Index (GI)
Standard Deviation 0.8
|
1.5 Gingival Index (GI)
Standard Deviation 0.7
|
|
Gingival Index
T2 (incisor)
|
1.1 Gingival Index (GI)
Standard Deviation 0.5
|
1.7 Gingival Index (GI)
Standard Deviation 0.7
|
1.5 Gingival Index (GI)
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatmentAn 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
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Bleeding Index
T0 (premolar)
|
0.5 Bleeding index (BI)
Standard Deviation 0.8
|
0.6 Bleeding index (BI)
Standard Deviation 0.7
|
0.6 Bleeding index (BI)
Standard Deviation 0.7
|
|
Bleeding Index
T1 (premolar)
|
0.6 Bleeding index (BI)
Standard Deviation 0.8
|
1.4 Bleeding index (BI)
Standard Deviation 1.2
|
1.3 Bleeding index (BI)
Standard Deviation 1.0
|
|
Bleeding Index
T2(Premolar)
|
0.5 Bleeding index (BI)
Standard Deviation 0.7
|
0.7 Bleeding index (BI)
Standard Deviation 1.1
|
0.8 Bleeding index (BI)
Standard Deviation 0.1
|
|
Bleeding Index
T0 (incisor)
|
0.7 Bleeding index (BI)
Standard Deviation 0.8
|
0.9 Bleeding index (BI)
Standard Deviation 1
|
0.8 Bleeding index (BI)
Standard Deviation 1
|
|
Bleeding Index
T1 (incisor)
|
0.5 Bleeding index (BI)
Standard Deviation 0.6
|
1.1 Bleeding index (BI)
Standard Deviation 1
|
1.2 Bleeding index (BI)
Standard Deviation 0.9
|
|
Bleeding Index
T2 (incisor)
|
0.5 Bleeding index (BI)
Standard Deviation 0.8
|
1.6 Bleeding index (BI)
Standard Deviation 1.2
|
1.3 Bleeding index (BI)
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatmentTo 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).
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Total Bacterial Count
T0
|
7.9 CFU/ml
Standard Deviation 13.8
|
4.7 CFU/ml
Standard Deviation 15.8
|
4.4 CFU/ml
Standard Deviation 7.8
|
|
Total Bacterial Count
T1
|
6 CFU/ml
Standard Deviation 9.9
|
32.7 CFU/ml
Standard Deviation 92.4
|
10.9 CFU/ml
Standard Deviation 18.1
|
|
Total Bacterial Count
T2
|
10.6 CFU/ml
Standard Deviation 14.7
|
9.6 CFU/ml
Standard Deviation 11.2
|
14.8 CFU/ml
Standard Deviation 15
|
SECONDARY outcome
Timeframe: T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatmentTo 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)
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
S.Mutans Count
T0
|
0.8 CFU/ml
Standard Deviation 3.7
|
1 CFU/ml
Standard Deviation 2.1
|
1.1 CFU/ml
Standard Deviation 2.1
|
|
S.Mutans Count
T1
|
0.5 CFU/ml
Standard Deviation 2
|
0.8 CFU/ml
Standard Deviation 2.0
|
1.6 CFU/ml
Standard Deviation 6.5
|
|
S.Mutans Count
T2
|
0.2 CFU/ml
Standard Deviation 0.5
|
0.5 CFU/ml
Standard Deviation 1.2
|
9.9 CFU/ml
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: T0-T2: 18 months of treatmentRoot 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).
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)
|
0.3 millimeter (mm)
Standard Deviation 0.4
|
0.9 millimeter (mm)
Standard Deviation 0.9
|
0.8 millimeter (mm)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: T0-T2: 18 months of treatmentRoot resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)
Outcome measures
| Measure |
Clear Aligner Appliance
n=21 Participants
Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Self-ligating Appliance
n=16 Participants
Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
Conventional Bracket Appliance
n=19 Participants
Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement.
|
|---|---|---|---|
|
Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm)
|
0.17 millimeter (mm)
Standard Deviation 0.1
|
0.16 millimeter (mm)
Standard Deviation 0.11
|
0.21 millimeter (mm)
Standard Deviation 0.13
|
Adverse Events
Clear Aligner Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-ligating Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Bracket Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Madhur Upadhyay, Director Orthodontic Clinic, Assistant Professor
University of Connecticut Health
Phone: 860-679-3729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place