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

Not Applicable

Completed

• Conditions: Carious Lesion
• Interventions: Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent; Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent

• Registration Number: NCT05744648
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-05
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-02-27
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Composite resin restoration without Titania nanoparticle incorporated bonding agent	Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent
Group A	Composite resin restoration using Titania nanoparticle reinforced bonding agent	Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent

Primary Outcome Measures

Name	Time	Method
Post-restorative sensitivity in composite resin restoration	1 month	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

Trial Locations

Locations (1)

School of Dentistry, Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Pakistan