Sensitivity, Tooth
Conditions
Brief summary
To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.
Detailed description
The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies. The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching. The different adhesive gluma desensitizer application groups are randomly divided into 6 groups, 1. Total etch control group (No gluma desensitizer application) 2. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching 3. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching 4. Self etch control group (No gluma desensitizer application) 5. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching 6. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
Interventions
OTHERGLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity
Sponsors
Tamil Nadu Dr.M.G.R.Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Occlusal cavitated caries in maxillary and mandibular first and second molars
Exclusion criteria
* Occlusal caries with axial or proximal extension * Teeth with periodontal treatment within last three months * Teeth with cracks * Teeth to be taken as abutment for prosthesis * Patients with psychiatric treatment * Patients in orthodontic treatment or going to need orthodontic treatment * Patients under dentin hypersensitivity or using desensitizer treatment * Patients not willing for post treatment follow up * Patients having any other teeth with pain or sensitivity symptoms * Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 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 |
Countries
India
Participant flow
Recruitment details
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
Pre-assignment details
Of 570 enrolled participants, out of these 546 met the inclusion criteria and were randomized to study groups
Participants by arm
| Arm | Count |
|---|---|
| Total Etch (TE)Control Group No gluma desensitizer application | 91 |
| 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 | 91 |
| 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 | 91 |
| Self Etch (SE) Control Group No gluma desensitizer application | 91 |
| 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 | 91 |
| 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 | 91 |
| Total | 546 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 | 7 | 7 | 7 | 7 |
Baseline characteristics
| Characteristic | Total Etch (TE)Control Group | TE - GLUMA Application Prior to Acid Etching | TE - GLUMA Application After Acid Etching | Self Etch (SE) Control Group | SE - GLUMA Application Prior to Acid Etching | SE - GLUMA Application After Acid Etching | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 8 | 28 years STANDARD_DEVIATION 8 | 27 years STANDARD_DEVIATION 8 | 28 years STANDARD_DEVIATION 9 | 30 years STANDARD_DEVIATION 8 | 27 years STANDARD_DEVIATION 7 | 28.37 years STANDARD_DEVIATION 7.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 91 Participants | 91 Participants | 91 Participants | 91 Participants | 91 Participants | 91 Participants | 546 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 91 participants | 91 participants | 91 participants | 91 participants | 91 participants | 91 participants | 546 participants |
| Sex: Female, Male Female | 29 Participants | 39 Participants | 28 Participants | 42 Participants | 10 Participants | 35 Participants | 183 Participants |
| Sex: Female, Male Male | 62 Participants | 52 Participants | 63 Participants | 49 Participants | 81 Participants | 56 Participants | 363 Participants |
| Visual Analogue Scale (VAS) | 0.86 units on a scale STANDARD_DEVIATION 1.67 | 1.72 units on a scale STANDARD_DEVIATION 2.15 | 1.16 units on a scale STANDARD_DEVIATION 2.07 | 1.88 units on a scale STANDARD_DEVIATION 2.25 | 0.63 units on a scale STANDARD_DEVIATION 1.05 | 2.11 units on a scale STANDARD_DEVIATION 2.4 | 1.39 units on a scale STANDARD_DEVIATION 1.93 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 |
| other Total, other adverse events | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 84 |
Outcome results
Primary
Number of Participants With Post-operative Sensitivity Having VAS Score >3
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
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 14 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| Self Etch (SE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 16 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 15 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 21 Participants |
Comparison: The sample size was estimated to be 504 using G Power software with 95% power and alpha value set to 0.05. The participants were randomly divided to 6 groups with randomizer.org. The statistical analysis was carried out using SPSS 23 software to compare the mean pain scores between the six study groups using kruskal Wallis test.p-value: 0.05Kruskal-Wallis
Primary
Number of Participants With Post-operative Sensitivity Having VAS Score >3
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
Time frame: 48 hours
Population: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 14 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| Self Etch (SE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 13 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 4 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 11 Participants |
Primary
Number of Participants With Post-operative Sensitivity Having VAS Score >3
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
Time frame: 1 week
Population: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 3 Participants |
| Self Etch (SE) Control Group | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 9 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 2 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
Secondary
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
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
Time frame: 24 hours
Population: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 14 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| Self Etch (SE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 16 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 15 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 7 Participants |
Secondary
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
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
Time frame: 48 hours
Population: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 14 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 12 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| Self Etch (SE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 13 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 4 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 3 Participants |
Secondary
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
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
Time frame: 1 week
Population: Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Etch (TE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| TE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| TE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 6 Participants |
| Self Etch (SE) Control Group | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 7 Participants |
| SE - GLUMA Application Prior to Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 2 Participants |
| SE - GLUMA Application After Acid Etching | Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 | 2 Participants |