Evaluating Gluma desensitizer for tooth sensitivity after dental restorations
Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
NA · Tamil Nadu Dr.M.G.R.Medical University · NCT04248803
This study is testing if Gluma desensitizer can help reduce tooth sensitivity after getting fillings in molars, by trying different ways and times to apply it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 15 Years to 70 Years |
| Sex | All |
| Sponsor | Tamil Nadu Dr.M.G.R.Medical University (other) |
| Locations | 1 site (Madurai, Tamil Nadu) |
| Trial ID | NCT04248803 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Gluma desensitizer in managing immediate post-treatment sensitivity following posterior occlusal composite restorations in molar teeth. Participants will be randomly assigned to six groups based on different adhesive bonding strategies and the timing of Gluma application, either before or after acid etching. The primary focus is to determine how well Gluma can control sensitivity compared to control groups without its application. Secondary objectives include comparing sensitivity levels based on the timing of the desensitizer application.
Who should consider this trial
Good fit: Ideal candidates include individuals with occlusal cavitated caries in their maxillary and mandibular first and second molars.
Not a fit: Patients with occlusal caries extending to axial or proximal areas, or those with other dental issues such as cracks or recent periodontal treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce post-treatment sensitivity for patients receiving composite restorations.
How similar studies have performed: While similar approaches have been explored, the specific application timing of Gluma desensitizer in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madurai, Tamil Nadu
- CSI College of Dental Sciences and Research — Madurai, Tamil Nadu, India (RECRUITING)
Study contacts
- Study coordinator: Geeth Deepika, MDS
- Email: geethdeepika@gmail.com
- Phone: 9952331820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sensitivity, Tooth