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To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total etch control group | No Intervention | No gluma desensitizer application | |
| TE - GLUMA application prior to acid etching | Experimental | TE- Total Etch GLUMA - Desensitizing agent |
|
| TE - GLUMA application after acid etching | Experimental | TE- Total Etch GLUMA - Desensitizing agent |
|
| Self etch control group | No Intervention | No gluma desensitizer application | |
| SE - GLUMA application prior to acid etching | Experimental | SE - Self Etch GLUMA - Desensitizing agent |
|
| SE - GLUMA application after acid etching | Experimental | SE - Self Etch GLUMA - Desensitizing agent |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLUMA (Kulzer GmbH, Germany) desensitizing agent | Other | GLUMA desensitizer is used to reduce tooth sensitivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| 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 | 48 hours |
| 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 | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GEETH DEEPIKA, MDS | TN MGR MEDICAL UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSI College of Dental Sciences and Research | Madurai | Tamil Nadu | 625 001 | India |
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Of 570 enrolled participants, out of these 546 met the inclusion criteria and were randomized to study groups
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Etch (TE) Control Group | No gluma desensitizer application |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Self Etch (SE) Control Group | No gluma desensitizer application |
| FG004 | 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 |
| FG005 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 570 participants were enrolled for the study of which only 546 participants met the inclusion criteria which is been described earlier. The participants who met the inclusion criteria were randomly assigned to 6 study groups with 91 participants in each group
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Etch (TE)Control Group | No gluma desensitizer application |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Count of Participants | Participants | 24 hours |
|
The study began enrolling participants from February 6, 2020 to February 20, 2025. The adverse events were thoroughly examined for each participant who was enrolled in this clinical trial started from their baseline period at the end of 24 hours till their final visit at the end of 1 week. The last participant was recruited on February 13, 2025 and adverse events were examined with the study completion on February 20, 2025. The adverse events time frame for this study would be "1 Week".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Etch Control Group | No gluma desensitizer application | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Geeth Deepika | TamilNadu MU | 9952331820 | geethdeepika@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2025 | Sep 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C044372 | Gluma |
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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 |
| 48 hours |
| 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 | 1 week |
| BG002 | 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 |
| BG003 | Self Etch (SE) Control Group | No gluma desensitizer application |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | All participants belong to the Indian Subcontinent (Asian). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Visual Analogue Scale (VAS) | A Visual Analogue Scale (VAS) is one of the pain rating scale ranging from 1 to 10 the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous. often categorized as none (VAS=0), mild (VAS=1-3), moderate (VAS=4-6)and severe (VAS=7-10). VAS is widely used due to its simplicity and adaptability to a broad range of populations and settings. | Mean | Standard Deviation | units on a scale |
|
| OG002 | 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 |
| OG003 | Self Etch (SE) Control Group | No gluma desensitizer application |
| OG004 | 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 |
| OG005 | 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 |
|
|
|
| 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 | 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 48 hours | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 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 | 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 1 week | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 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 | Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 24 hours | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 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 | Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 48 hours | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 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 | Post operative sensitivity either stimulus based or spontaneous were analyzed using VAS ranging from 1 - 10 at the end of 1 week | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | 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 | 0 | 84 | 0 | 84 | 0 | 84 |
| EG002 | 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 | 0 | 84 | 0 | 84 | 0 | 84 |
| EG003 | Self Etch Control Group | No gluma desensitizer application | 0 | 84 | 0 | 84 | 0 | 84 |
| EG004 | 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 | 0 | 84 | 0 | 84 | 0 | 84 |
| EG005 | 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 | 0 | 84 | 0 | 84 | 0 | 84 |
The PIs of the current study have no sponsors. (Self-sponsored study)