Skip to main content
Clinical Trials/NCT05744648
NCT05744648
Completed
Not Applicable

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

Pakistan Institute of Medical Sciences1 site in 1 country60 target enrollmentJanuary 5, 2023
ConditionsCarious Lesion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carious Lesion
Sponsor
Pakistan Institute of Medical Sciences
Enrollment
60
Locations
1
Primary Endpoint
Post-restorative sensitivity in composite resin restoration
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2023
End Date
June 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

NEHAL AMIR

Principal Investigator

Pakistan Institute of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-restorative sensitivity in composite resin restoration

Time Frame: 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

Study Sites (1)

Loading locations...

Similar Trials