Trial Outcomes & Findings for Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite (NCT NCT04248803)
NCT ID: NCT04248803
Last Updated: 2025-10-17
Results Overview
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
570 participants
Primary outcome timeframe
24 hours
Results posted on
2025-10-17
Participant Flow
Participants were recruited from the Out Patient Department of Conservative Dentistry and Endodontics with a chief complaint of decayed tooth during the period from 2020 to 2024. The first patient was enrolled on February 6,2020 and the last patient was enrolled on February 20, 2025
Of 570 enrolled participants, out of these 546 met the inclusion criteria and were randomized to study groups
Participant milestones
| Measure |
Total Etch (TE) Control Group
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
91
|
91
|
91
|
91
|
|
Overall Study
COMPLETED
|
84
|
84
|
84
|
84
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
7
|
7
|
7
|
7
|
Reasons for withdrawal
| Measure |
Total Etch (TE) Control Group
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
7
|
7
|
7
|
7
|
Baseline Characteristics
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
Baseline characteristics by cohort
| Measure |
Total Etch (TE)Control Group
n=91 Participants
No gluma desensitizer application
|
TE - GLUMA Application Prior to Acid Etching
n=91 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application After Acid Etching
n=91 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=91 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=91 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=91 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 8 • n=5 Participants
|
28 years
STANDARD_DEVIATION 8 • n=7 Participants
|
27 years
STANDARD_DEVIATION 8 • n=5 Participants
|
28 years
STANDARD_DEVIATION 9 • n=4 Participants
|
30 years
STANDARD_DEVIATION 8 • n=21 Participants
|
27 years
STANDARD_DEVIATION 7 • n=8 Participants
|
28.37 years
STANDARD_DEVIATION 7.97 • n=8 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
183 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
363 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
91 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
91 Participants
n=8 Participants
|
546 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
India
|
91 participants
n=5 Participants
|
91 participants
n=7 Participants
|
91 participants
n=5 Participants
|
91 participants
n=4 Participants
|
91 participants
n=21 Participants
|
91 participants
n=8 Participants
|
546 participants
n=8 Participants
|
|
Visual Analogue Scale (VAS)
|
0.86 units on a scale
STANDARD_DEVIATION 1.67 • n=5 Participants
|
1.72 units on a scale
STANDARD_DEVIATION 2.15 • n=7 Participants
|
1.16 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
1.88 units on a scale
STANDARD_DEVIATION 2.25 • n=4 Participants
|
0.63 units on a scale
STANDARD_DEVIATION 1.05 • n=21 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 2.40 • n=8 Participants
|
1.39 units on a scale
STANDARD_DEVIATION 1.93 • n=8 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 84 participants in each group were analyzed for post operative sensitivity using visual analogue scale (VAS) ranging from 1 -10 at the end of 24 hours.
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Post-operative Sensitivity Having VAS Score >3
|
14 Participants
|
12 Participants
|
6 Participants
|
16 Participants
|
15 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 48 hours
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Post-operative Sensitivity Having VAS Score >3
|
14 Participants
|
12 Participants
|
6 Participants
|
13 Participants
|
4 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 1 week
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Post-operative Sensitivity Having VAS Score >3
|
6 Participants
|
12 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 24 hours
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
|
14 Participants
|
12 Participants
|
6 Participants
|
16 Participants
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 48 hours
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
|
14 Participants
|
12 Participants
|
6 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 1 week
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Outcome measures
| Measure |
Total Etch (TE) Control Group
n=84 Participants
No gluma desensitizer application
|
TE - GLUMA Application After Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
TE - GLUMA Application Prior to Acid Etching
n=84 Participants
TE- Total Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
Self Etch (SE) Control Group
n=84 Participants
No gluma desensitizer application
|
SE - GLUMA Application Prior to Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
SE - GLUMA Application After Acid Etching
n=84 Participants
SE - Self Etch GLUMA - Desensitizing agent
GLUMA (Kulzer GmbH, Germany) desensitizing agent: GLUMA desensitizer is used to reduce tooth sensitivity
|
|---|---|---|---|---|---|---|
|
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
|
6 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Total Etch Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TE - GLUMA Application Prior to Acid Etching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TE - GLUMA Application After Acid Etching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self Etch Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SE - GLUMA Application Prior to Acid Etching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SE - GLUMA Application After Acid Etching
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
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs of the current study have no sponsors. (Self-sponsored study)
- Publication restrictions are in place
Restriction type: OTHER