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OpenTrials
Completed

NCT Number: NCT06242184

Post-operative Sensitivity in Resin Composites

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

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Key information

Conditions

Caries,Dental Dental Caries Dentin Sensitivity Sensitivity, Tooth Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

About this study

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • participants with goof general health status
  • Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
  • Vital and Periodontally sound teeth

Exclusion criteria

  • Patient with Temporomandibular dysfunction
  • History of spontaneous pain
  • Endodontically treated teeth
  • Patient on analgesics within the past two weeks

Treatment and study plan

Group A(Nano-fortified Adhesive)

Procedure

Nano-fortified dentin adhesive

Group B(Adhesive without nanoparticles)

Procedure

Conventional adhesives without nanoparticles

Primary outcomes

  1. Post-operative sensitivity

    Time frame: One month

    Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2024
Registry last updated
Feb 6, 2024

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.

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