Trial Outcomes & Findings for Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains (NCT NCT01733888)
NCT ID: NCT01733888
Last Updated: 2022-05-25
Results Overview
Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Immediate
Results posted on
2022-05-25
Participant Flow
Participant milestones
| Measure |
In-office Bleaching
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
|
Resin Infiltration
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
|
Resin Infiltration Twice
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice.
|
In-office Bleaching + Resin Infiltration
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
Baseline characteristics by cohort
| Measure |
In-office Bleaching
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
|
Resin Infiltration
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
|
Resin Infiltration Twice
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice.
|
In-office Bleaching + Resin Infiltration
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
11.1 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
11.6 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
11.1 years
STANDARD_DEVIATION 0.8 • n=4 Participants
|
11.3 years
STANDARD_DEVIATION 0.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hindu
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Sikh
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: ImmediatePre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
Outcome measures
| Measure |
In-office Bleaching
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
|
Resin Infiltration
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
|
Resin Infiltration Twice
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice.
|
In-office Bleaching + Resin Infiltration
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
|
|---|---|---|---|---|
|
Esthetic Changes
|
1.90 score on a scale
Standard Deviation 0.95
|
5.50 score on a scale
Standard Deviation 1.00
|
5.53 score on a scale
Standard Deviation 1.97
|
5.35 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: ImmediatePre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
Outcome measures
| Measure |
In-office Bleaching
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
|
Resin Infiltration
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
|
Resin Infiltration Twice
n=20 Participants
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice.
|
In-office Bleaching + Resin Infiltration
n=20 Participants
In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).
|
|---|---|---|---|---|
|
Improvement in Brown Stains/ Change in White Opacities
|
1.53 score on a scale
Standard Deviation 1.07
|
4.98 score on a scale
Standard Deviation 0.98
|
5.18 score on a scale
Standard Deviation 1.29
|
4.40 score on a scale
Standard Deviation 1.59
|
Adverse Events
In-office Bleaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resin Infiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resin Infiltration Twice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
In-office Bleaching + Resin Infiltration
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
Manager Clinical Research
DMG Dental Material Gesellschaft
Phone: +494084006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place