Clinical trial NCT04248803: 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
Overall status: RECRUITING
Phase: NA
Conditions: Sensitivity, Tooth
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 504
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: post-operative sensitivity
timeFrame: 24 hours
measure: post-operative sensitivity
timeFrame: 48 hours
measure: post-operative sensitivity
timeFrame: 1 week
Secondary outcomes:
measure: post-operative sensitivity - stimulus based ( hot/cold) or spontaneous
timeFrame: 24 hours
measure: post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
timeFrame: 48 hours
measure: post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
timeFrame: 1 week
Other outcomes:
Locations:
city: Madurai
country: India
facility: CSI College of Dental Sciences and Research
state: Tamil Nadu
Study officials:
References: