Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite
- Conditions
- Sensitivity, Tooth
- Interventions
- Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
- Registration Number
- NCT04248803
- Lead Sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 504
- Occlusal cavitated caries in maxillary and mandibular first and second molars
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TE - GLUMA application prior to acid etching GLUMA (Kulzer GmbH, Germany) desensitizing agent TE- Total Etch GLUMA - Desensitizing agent TE - GLUMA application after acid etching GLUMA (Kulzer GmbH, Germany) desensitizing agent TE- Total Etch GLUMA - Desensitizing agent SE - GLUMA application prior to acid etching GLUMA (Kulzer GmbH, Germany) desensitizing agent SE - Self Etch GLUMA - Desensitizing agent SE - GLUMA application after acid etching GLUMA (Kulzer GmbH, Germany) desensitizing agent SE - Self Etch GLUMA - Desensitizing agent
- Primary Outcome Measures
Name Time Method post-operative sensitivity 1 week 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
Name Time Method post-operative sensitivity - stimulus based ( hot/cold) or spontaneous 24 hours 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 1 week 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
Trial Locations
- Locations (1)
CSI College of Dental Sciences and Research
🇮🇳Madurai, Tamil Nadu, India