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

Sensitivity, Tooth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248803
• Other study ID #: CSICDSR
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Tamil Nadu Dr.M.G.R.Medical University
• Contact: Geeth Deepika, MDS
• Phone: 9952331820
• Email: geethdeepika[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: May 1, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Sensitivity, Tooth

Intervention

Other:
• GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity

Locations

Country	Name	City	State
India	CSI College of Dental Sciences and Research	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Tamil Nadu Dr.M.G.R.Medical University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative sensitivity	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
Primary	post-operative sensitivity	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
Primary	post-operative sensitivity	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	post-operative sensitivity - stimulus based ( hot/cold) or spontaneous	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	24 hours
Secondary	post-operative sensitivity -stimulus based ( hot/cold) or spontaneous	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	48 hours
Secondary	post-operative sensitivity -stimulus based ( hot/cold) or spontaneous	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	1 week