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Completed

NCT Number: NCT05024669

Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations

Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.

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Key information

Conditions

Sensitivity Hypersensitivity Immune System Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harisha Dewan

Jizan, 45142, Saudi Arabia

About this study

A double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class I cavity were randomly assigned to 4 groups of 20 patients each: Group C (Control group), Group GL (Gluma group), Group SF (Shield Force Plus group), and Group TC (Telio CS group). The class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. The postoperative pain/sensitivity level was recorded according to the Visual Analogue Scale (VAS) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The selection criteria:

  • Age was 20-45 years.
  • Vital teeth, (electric pulp test)
  • Apical periodontal ligament space radiographically identified
  • The remaining dentin thickness at least 1mm.

Exclusion criteria

  • Restored, periodontally weak nonvital teeth are excluded.

Treatment and study plan

Gluma desensitiser

Combination Product

Gluma desensitiser was used before restoration.

Sheildforce Plus desensitiser

Combination Product

Sheildforce Plus desensitiser was used before restoration.

Telio CS desensitiser

Combination Product

Telio CS desensitiser was used before restoration.

Primary outcomes

  1. Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

    Time frame: Within 24 hours

    The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar.

  2. Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

    Time frame: After one week

    The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar.

  3. Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

    Time frame: after one month

    The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar.

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

Efficacy of Three Commercially Available Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations: A Randomized Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

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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