Skip to main content
OpenTrials
Completed

NCT Number: NCT05744648

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Composite resin restoration using Titania nanoparticle reinforced bonding agent

Procedure

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

Composite resin restoration without Titania nanoparticle incorporated bonding agent

Procedure

Composite resin restoration without Titania nanoparticle incorporated bonding agent

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.