N/A
N=546
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
Sensitivity, Tooth
Bottom Line
View on ClinicalTrials.gov: NCT04248803 ↗Enrolled (actual)
546
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants With Post-operative Sensitivity Having VAS Score >3 — 14; 12; 6; 16 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GLUMA (Kulzer GmbH, Germany) desensitizing agent (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post-operative Sensitivity Having VAS Score >3 |
6; 12; 3; 9; 2; 12 | — |
| PRIMARY Number of Participants With Post-operative Sensitivity Having VAS Score >3 |
6; 12; 3; 9; 2; 12 | — |
| PRIMARY Number of Participants With Post-operative Sensitivity Having VAS Score >3 |
6; 12; 3; 9; 2; 12 | — |
| SECONDARY Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 |
6; 6; 6; 7; 2; 2 | — |
| SECONDARY Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 |
6; 6; 6; 7; 2; 2 | — |
| SECONDARY Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3 |
6; 6; 6; 7; 2; 2 | — |
Summary
To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.
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
Data sourced from ClinicalTrials.gov (NCT04248803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.