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Completed

NCT Number: NCT03792178

Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.

Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40 years old. They were divided into 2 main groups according to the packing technique of composite material; incremental Tetric Evoceram and Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric Evoceram composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30) were selected for Tetric Evoceram bulk fill composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the VAS line at home to indicate the intensity of pain at each assessment period.

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Key information

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Our results revealed that when the two composite types using self-etch adhesive system & total-etch adhesive system were evaluated; there was no statistically significant difference between the two composite types after 1 day, 1 week as well as 1 month.

When the two adhesive systems were compared using Bulk Fill composite & incremental Nano resin composite there was no statistically significant difference between the two adhesive systems after 1 day, 1 week as well as 1 month.

Using Bulk Fill composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week. There were no cases with hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.

Using Incremental Nano resin composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must show no signs of spontaneous dental or orofacial pain.
  • The presence of molar and premolar class II teeth requiring composite restorations for the treatment of primary carious lesions
  • The selected teeth should have an occlusal contact with natural or crowned antagonist teeth
  • The selected teeth should have a proximal contact with the adjacent teeth.
  • Shallow and mid-sized cavity depths will be included in the study .

Exclusion criteria

  • Increasing pre-operative sensitivity of the selected teeth.
  • Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations.
  • Teeth with old restorations or severely destructed dental crowns.
  • Teeth with spontaneous pain
  • Tempro-mandibular joint problems involving symptomatic pain.
  • Patients taking analgesics that could alter their normal pain perception level.
  • Pregnancy or breast feeding, acute and chronic systemic diseases, immunecompromised patients.

Treatment and study plan

bulk fill composite

Other

Composite resin dental material

Nano resin composite

Other

Dental composite material

Primary outcomes

  1. sensitivity

    Time frame: one month follow up

    post operative sensitivity

Sponsors and collaborators

Lead sponsor

Rasmia Mamdouh Ali Salem

Other

Collaborators

  • World Health Organization

Registry information

Acronym: EPSBN

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 3, 2019
Registry last updated
Jan 7, 2019

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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