Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT04248803
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2020-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
Sponsor:
Tamil Nadu Dr.M.G.R.Medical University
Organization:
Study Overview
Official Title:
Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: