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

Tamil Nadu Dr.M.G.R.Medical University

Status: Enrolling

Conditions: Sensitivity, Tooth

Treatments: Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent

Study type: Interventional

Funder types: Other

Identifiers

NCT04248803

CSICDSR

Details and patient eligibility

About

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

Full 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

Enrollment: 504 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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504 participants in 6 patient groups

Total etch control group

No Intervention group

Description:

No gluma desensitizer application

TE - GLUMA application prior to acid etching

Experimental group

Description:

TE- Total Etch GLUMA - Desensitizing agent

Treatment:

Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent

TE - GLUMA application after acid etching

Experimental group

Description:

TE- Total Etch GLUMA - Desensitizing agent

Treatment:

Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent

Self etch control group

No Intervention group

Description:

No gluma desensitizer application

SE - GLUMA application prior to acid etching

Experimental group

Description:

SE - Self Etch GLUMA - Desensitizing agent

Treatment:

Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent

SE - GLUMA application after acid etching

Experimental group

Description:

SE - Self Etch GLUMA - Desensitizing agent

Treatment:

Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent