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

P

Pakistan Institute of Medical Sciences

Status

Completed

Conditions

Carious Lesion

Treatments

Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent
Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent

Study type

Interventional

Funder types

Other

Identifiers

NCT05744648
SOD/ERB/2022/14

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Group A
Experimental group
Description:
Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent
Treatment:
Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent
Group B
Experimental group
Description:
Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent
Treatment:
Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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