Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
1 other identifier
interventional
570
1 country
1
Brief Summary
To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
February 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedResults Posted
Study results publicly available
October 20, 2025
CompletedOctober 20, 2025
September 1, 2025
5 years
January 28, 2020
April 23, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
24 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
48 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
1 week
Study Arms (6)
Total etch control group
NO INTERVENTIONNo gluma desensitizer application
TE - GLUMA application prior to acid etching
EXPERIMENTALTE- Total Etch GLUMA - Desensitizing agent
TE - GLUMA application after acid etching
EXPERIMENTALTE- Total Etch GLUMA - Desensitizing agent
Self etch control group
NO INTERVENTIONNo gluma desensitizer application
SE - GLUMA application prior to acid etching
EXPERIMENTALSE - Self Etch GLUMA - Desensitizing agent
SE - GLUMA application after acid etching
EXPERIMENTALSE - Self Etch GLUMA - Desensitizing agent
Interventions
GLUMA desensitizer is used to reduce tooth sensitivity
Eligibility Criteria
You may qualify if:
- Occlusal cavitated caries in maxillary and mandibular first and second molars
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CSI College of Dental Sciences and Research
Madurai, Tamil Nadu, 625 001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Limited generalizability owing to similar ethnicity and race among all the study participants. 2. Limited reliability of subjective scales such as VAS.
Results Point of Contact
- Title
- Dr Geeth Deepika
- Organization
- TamilNadu MU
Study Officials
- PRINCIPAL INVESTIGATOR
GEETH DEEPIKA, MDS
TN MGR MEDICAL UNIVERSITY
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 28, 2020
First Posted
January 30, 2020
Study Start
February 6, 2020
Primary Completion
February 20, 2025
Study Completion
February 20, 2025
Last Updated
October 20, 2025
Results First Posted
October 20, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share