Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity

Study Overview
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Brief Summary
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Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations. Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.

Detailed Description
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In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.

Official Title
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Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial

Conditions
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Carious Lesion

Intervention / Treatment
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* Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent
* Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with good general health Selected teeth should be vital and periodontally healthy Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm Defective previous restorations in need of replacement (secondary caries/fractures) Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth Exclusion Criteria: Patients with Temporomandibular disorders Extremely poor oral hygiene status Teeth with very deep carious lesions Teeth with periapical or periodontal pathology Patients taking anti-inflammatory, analgesics or psychotropic drugs History of spontaneous pain Previously root canal treated teeth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent | Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent<br>* Each group will receive Composite resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used<br>|
| Experimental: Group B<br>Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent | Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent<br>* Composite resin restoration without Titania nanoparticle incorporated bonding agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-restorative sensitivity in composite resin restoration | Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 means worst outcomes | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania