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Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

Primary Purpose

Sensitivity, Tooth

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
GLUMA (Kulzer GmbH, Germany) desensitizing agent
Sponsored by
Tamil Nadu Dr.M.G.R.Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitivity, Tooth

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CSI College of Dental Sciences and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

Total etch control group

TE - GLUMA application prior to acid etching

TE - GLUMA application after acid etching

Self etch control group

SE - GLUMA application prior to acid etching

SE - GLUMA application after acid etching

Arm Description

No gluma desensitizer application

TE- Total Etch GLUMA - Desensitizing agent

TE- Total Etch GLUMA - Desensitizing agent

No gluma desensitizer application

SE - Self Etch GLUMA - Desensitizing agent

SE - Self Etch GLUMA - Desensitizing agent

Outcomes

Primary Outcome Measures

post-operative sensitivity
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
post-operative sensitivity
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
post-operative sensitivity
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

Secondary Outcome Measures

post-operative sensitivity - stimulus based ( hot/cold) or spontaneous
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 -stimulus based ( hot/cold) or spontaneous
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 -stimulus based ( hot/cold) or spontaneous
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

Full Information

First Posted
January 28, 2020
Last Updated
February 10, 2020
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04248803
Brief Title
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, Total etch control group (No gluma desensitizer application) Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching Self etch control group (No gluma desensitizer application) Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total etch control group
Arm Type
No Intervention
Arm Description
No gluma desensitizer application
Arm Title
TE - GLUMA application prior to acid etching
Arm Type
Experimental
Arm Description
TE- Total Etch GLUMA - Desensitizing agent
Arm Title
TE - GLUMA application after acid etching
Arm Type
Experimental
Arm Description
TE- Total Etch GLUMA - Desensitizing agent
Arm Title
Self etch control group
Arm Type
No Intervention
Arm Description
No gluma desensitizer application
Arm Title
SE - GLUMA application prior to acid etching
Arm Type
Experimental
Arm Description
SE - Self Etch GLUMA - Desensitizing agent
Arm Title
SE - GLUMA application after acid etching
Arm Type
Experimental
Arm Description
SE - Self Etch GLUMA - Desensitizing agent
Intervention Type
Other
Intervention Name(s)
GLUMA (Kulzer GmbH, Germany) desensitizing agent
Intervention Description
GLUMA desensitizer is used to reduce tooth sensitivity
Primary Outcome Measure Information:
Title
post-operative sensitivity
Description
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
Title
post-operative sensitivity
Description
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
Title
post-operative sensitivity
Description
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
Secondary Outcome Measure Information:
Title
post-operative sensitivity - stimulus based ( hot/cold) or spontaneous
Description
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
Title
post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
Description
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
Title
post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geeth Deepika, MDS
Phone
9952331820
Email
geethdeepika@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anand Sherwood, MDS,Ph.D
Phone
9443805150
Email
anand.sherwood@gmail.com
Facility Information:
Facility Name
CSI College of Dental Sciences and Research
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anand Sherwood, MDS,Ph.D
Phone
9791443950
Email
anand.sherwood@gmail.com
First Name & Middle Initial & Last Name & Degree
Ernest Prince, MDS
Phone
9042743070
Email
ernestprince@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
from May 2021 to May 2025

Learn more about this trial

Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

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