Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
NCT ID: NCT04248803
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
570 participants
INTERVENTIONAL
2020-02-06
2025-02-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Total etch control group
No gluma desensitizer application
No interventions assigned to this group
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
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
Self etch control group
No gluma desensitizer application
No interventions assigned to this group
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
Interventions
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GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
15 Years
70 Years
ALL
Yes
Sponsors
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Tamil Nadu Dr.M.G.R.Medical University
OTHER
Responsible Party
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Dr. Geeth Deepika
Principal Investigator
Principal Investigators
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GEETH DEEPIKA, MDS
Role: PRINCIPAL_INVESTIGATOR
TN MGR MEDICAL UNIVERSITY
Locations
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CSI College of Dental Sciences and Research
Madurai, Tamil Nadu, India
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CSICDSR
Identifier Type: -
Identifier Source: org_study_id
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